This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.
The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Not intended for use in the coronary or cerebral vasculature.
This device is not designed for use with atherectomy devices.
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.
Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.
Do Not:
• Push, auger, withdraw, or torque a guide wire that meets excessive resistance. • Torque a guide wire if the tip becomes entrapped within the vasculature. • Allow the guide wire tip to remain in a prolapsed condition. • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.
Do:
• Advance or withdraw the guide wire slowly. • Use the radiopaque marker of the interventional device to confirm position. • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire. • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance. • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma. • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall. • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use.
Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.
Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.
Hi-Torque Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.
Potential Adverse Events associated with use of this device may include the following but are not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.
MAT-2307869 v1.0
INDICATIONS FOR USE
The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. The guide wires may also be used with compatible stent devices during therapeutic procedures.
The guide wires may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
CONTRAINDICATIONS
The Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire are not intended for use in the coronary or cerebral vasculature.
WARNINGS
This device is not designed for use with atherectomy devices. The safety and effectiveness of the use of the Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire with atherectomy devices are not established.
Use the guide wire prior to the “Use-by date” specified on the package. This device is designed and intended for ONE TIME USE ONLY. Do not resterilize and / or reuse. The safety and effectiveness of this device have not been established after being reprocessed for multiple uses.
Use extreme caution and careful judgement in patients for whom anticoagulation is not indicated.
If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.
Persons with known history of allergies to any of the components of this device listed below may develop an allergic reaction to this guide wire: stainless steel, nitinol (nickel-titanium alloy), platinum-nickel alloy, polytetrafluoroethylene (PTFE) coating, silicone-based hydrophobic coating, tungsten polymer sleeve, urethane, polyvinylpyrrolidone (PVP) coating, tin-silver alloy, gold-tin alloy, and epoxy adhesive. Prior to its use on the patient, the patient should be counseled on the materials contained in the device, and a thorough history of allergies must be discussed.
This device has a hydrophilic coating at the distal end of the device and hydrophobic coatings at the proximal end of the device that increases the lubricity of the guide wire surface for lengths as specified in the table below:
| Product | Type of Coating and Coating Length at the Distal End | Type of Coating and Coating Length at the Proximal End | Hydrophobic PTFE Coating Location (Proximal) |
|---|---|---|---|
| Hi-Torque Command 14 ST, 210 cm | PVP Coating (Hydrophilic coating), 10 cm | Microglide Coating (Hydrophobic coating), 182 cm | Under Microglide Coating, 184 cm |
| Hi-Torque Command 14 ST, 300 cm | PVP Coating (Hydrophilic coating), 10 cm | Microglide Coating (Hydrophobic coating), 264.5 cm | Under Microglide Coating, 276 cm |
| Hi-Torque Command 14 MT, 210 cm | PVP Coating (Hydrophilic coating), 25 cm | Microglide Coating (Hydrophobic coating), 167 cm | Under Microglide Coating, 169 cm |
| Hi-Torque Command 14 MT, 300 cm | PVP Coating (Hydrophilic coating), 25 cm | Microglide Coating (Hydrophobic coating), 249.5 cm | Under Microglide Coating, 261 cm |
Refer to section PREPARATION FOR USE for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
Carefully observe the instructions under "Do Not" and "Do" below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.
Do Not:
Do:
PRECAUTIONS
The Hi-Torque Command™ 14 ST and MT Guide Wire Family has distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessels, observing the information in these instructions. The higher torque performance, stiffer distal ends, and / or higher advancement force may present a higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use.
Refer to the indication on the label and the Instructions for Use to confirm the appropriate vasculature that this guide wire may be used in. Failure to abide by the above recommendation may result in size mismatch of blood vessel and guide wire, which can result in vessel injury, such as, but not limited to, perforation, dissection, rupture, and avulsion.
Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.
It is recommended that the user determine the source of resistance, exercise caution when removing the device and / or other components as a unit, and exchange the device for a new one to complete the procedure.
Avoid abrasion of the coating. Do not withdraw or manipulate the coated guide wire through a metal cannula or sharp-edged object. Manipulation, advancement, and / or withdrawal through a metal device may result in destruction and / or separation of the outer coating, which may cause coating material to remain in the vasculature. This in turn may lead to unintended adverse events requiring additional intervention.
Do not soak the device for longer than 4 hours when the device is not in use. Avoid pre-soaking devices for longer than instructed, as this may impact the coating performance.
When wet, a hydrophilic coating increases the lubricity of the guide wire surface.
The coating swells when exposed to aqueous media; however, this does not have any impact on device use.
The integrity and performance of the device coating can be negatively impacted by preparation with incompatible media or solvents. Please take note of the following important recommendations:
Attempting to alter the shape of devices by bending, twisting, or similar methods beyond instructed methods may compromise the coating integrity, and that damage to the coating may not always be noticeable to the naked eye.
The safety and effectiveness of the Hi-Torque Command™ 14 ST Guide Wire and Hi-Torque Command™ 14 MT Guide Wire have not been established in the pediatric population.
ADVERSE EVENTS
Potential adverse events associated with use of this device may include the following but not limited to:
MAT-2407512 v1.0
INDICATIONS FOR USE
This Hi-Torque™ Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries.This guide wire may also be used with compatible stent devices during therapeutic procedures.
The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
CONTRAINDICATIONS
Not intended for use in the coronary or cerebral vasculature.
WARNINGS
This device is not designed for use with artherectomy devices.
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.
Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.
Do Not:
PRECAUTIONS
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use.
Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.
Avoid abrasion of the hydrophilic coating.
Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.
ADVERSE EVENTS (AEs)
Potential Adverse Events associated with use of this device may include the following but are not limited to:
MAT-2111768 v2.0
Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.
Hi-Torque wires are not intended for use in the coronary and cerebral vasculature or in patients judged not acceptable for percutaneous intervention.
A guide wire is a delicate instrument and must not be advanced, withdrawn, or torqued if resistance is met. Guide wire manipulations must always be observed under fluoroscopy.
The Hi-Torque family of guide wires has distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessel, observing the information in these instructions. The higher torque performance, stiffer distal ends, and / or higher advancement force may present a higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.
If the guide wire is removed and is to be re- inserted, it must be inspected for signs of damage (weakened or kinked segments) prior to re-introduction. Do not re- introduce if guide wire is weakened or kinked.
Do Not:
Do:
MAT-2307413 v1.0
Abbott Medical Guidewires are intended for use in the percutaneous introduction of catheters.
There are no known contraindications for these devices.
For Single Use Only! Single-use devices are designed and tested for only one patient application. These are disposable devices and are not designed for reprocessing and reuse. Reuse of designated “single-use” devices creates a risk of patient or user infections due to prior patient use and the difficulty in cleaning the narrow structures at material interfaces following direct blood contact. Contamination or reprocessing cleaning agent residues may lead to adverse patient reactions and may damage the device. Use of non-Abbott Medical packaging may compromise device functionality and sterility due to compromised protection from shipping and handling damage. The absence of labeling after reprocessing, may lead to misuse of the device and impaired traceability. Reprocessing and reuse may result in patient or user injury, permanent impairment or death.
Procedures requiring percutaneous catheter/guidewire introduction should not be attempted by physicians unfamiliar with the possible complications. Complications may occur during certain procedures but may not be limited to air embolism, hematoma formation, sepsis/infection, excessive bleeding, vessel damage.
MAT-2008757 v3.0
Abbott Medical guidewires are intended for use in the percutaneous introduction of catheters.
There are no known contraindications for this device.
Do not reuse this device. Discard after one procedure. Thorough cleaning of biological and foreign material is not possible. Adverse patient reactions may result from reuse of this device.
Procedures requiring percutaneous catheter/guidewire introduction should not be attempted by physicians unfamiliar with the possible complications. Complications may occur during certain procedures but may not be limited to air embolism, hematoma formation, sepsis/infection, excessive bleeding, vessel damage.
MAT-2008755 v2.0
Abbott Medical HydroSteer™ Torque Device is intended for use with HydroSteer™ or other guidewires to aid in manipulation of the wire.
There are no known contraindications for this device.
Do not reuse this device. Discard after one procedure. Thorough cleaning of biological and foreign material is not possible. Adverse patient reactions may result from reuse of this device.
Abbott Medical does not recommend a particular technique for the use of this device. The steps contained in the directions are for information purposes only. Each physician should evaluate their appropriateness according to individual patient condition and his or her medical training and experience.
Procedures requiring percutaneous catheter/guidewire introduction should not be attempted by physicians unfamiliar with the possible complications. Complications may occur during certain procedures but may not be limited to air embolism, hematoma formation, sepsis/infection, excessive bleeding, vessel damage.
MAT-2008756 v2.0
The Hi-Torque™ Steerable Guide Wire is intended for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels.
The Hi-Torque™ Steerable Guide Wire is not intended for use in the coronary or neurovasculature.
The Hi-Torque™ Steerable Guide Wire is not intended for use in the coronary or neurovasculature.
This device is designed and intended for ONE-TIME USE ONLY. DO NOT RESTERILIZE AND / OR REUSE.
Observe all guide wire movement in the vessels. Before a guide wire is moved or torqued, the tip movement should be examined under fluoroscopy. Do not torque a guide wire without observing corresponding movement of the tip; otherwise, vessel trauma may occur.
Torquing a guide wire against resistance may cause guide wire damage and / or guide wire tip separation. Always advance or withdraw the guide wire slowly. Never push, auger, withdraw, or torque a guide wire which meets resistance. Resistance may be felt and / or observed under fluoroscopy by noting any buckling of the guide wire tip. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.
If the wire tip becomes entrapped within the vasculature, DO NOT TORQUE THE GUIDE WIRE.
Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform all exchanges slowly to prevent air entry and / or trauma. Wipe the wire before all exchanges.
When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and not against the vessel wall. Failure to do so may result in vessel trauma upon guide wire exit from the device. Use the radiopaque marker of the interventional device to confirm position.
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged wires. Using a damaged wire may result in vessel damage and / or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use.
Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.
Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.
MAT-2306607 v1.0
The Abbott Medical Steerable Guidewires facilitate placement of a catheter during diagnostic angiography and interventional procedures. The Steerable Guidewire can be accurately controlled to facilitate navigation through tortuous vessels and/or adjoining side branches.
For Single Use Only! Single-use devices are designed and tested for only one patient application. These are disposable devices and are not designed for reprocessing and reuse. Reuse of designated “single-use” devices creates a risk of patient or user infections due to prior patient use and the difficulty in cleaning the narrow structures at material interfaces following direct blood contact. Contamination or reprocessing cleaning agent residues may lead to adverse patient reactions and may damage the device. Use of non-Abbott Medical packaging may compromise device functionality and sterility due to compromised protection from shipping and handling damage. The absence of labeling after reprocessing, may lead to misuse of the device and impaired traceability. Reprocessing and reuse may result in patient or user injury, permanent impairment or death.
MAT-2008754 v2.0
Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal, and infrapopliteal arteries. This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Not intended for use in the cerebral vasculature.
This device is not designed for use with atherectomy devices. The safety and effectiveness of the use of this Hi-Torque™ Guide Wire with atherectomy devices are unestablished.
The lifetime of this device is the labeled shelf life. This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse. The safety and effectiveness of this device have not been established after being reprocessed for multiple uses.
This device has a hydrophilic coating at the distal end of the device for a length of 25.6 cm, and a silicone based hydrophobic coating at the proximal end for a length of 133 cm (on 190 cm wires) and 250 cm (on 300 cm wires), and a polytetrafluoroethylene (PTFE) hydrophobic coating at the proximal end for a length of 156.5 cm (on 190 cm wires) and 266.5 cm (on 300 cm wires).
Please refer to section PREPARATION FOR USE for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
Use extreme caution and careful judgement in patients for whom anticoagulation is not indicated.
If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.
The safety and effectiveness of this device have not been established, or is unknown, in vascular regions other than those specifically indicated.
This device contains stainless steel, platinum-nickel alloy, tin-silver alloy, gold-tin alloy, Microglide™ silicone coating, PTFE coating, polyvinylpyrrolidone (PVP) coating that may cause allergic or hypersensitivity reactions. Persons allergic to these may suffer an allergic reaction to this guide wire. Prior to its use on the patient, the patient should be counseled on the materials contained in the device, and a thorough history of allergies must be discussed.
Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.
Do Not:
Do:
For the Hi-Torque™ guide wire family only: The Hi-Torque family of guide wires have distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessel, observing the information in these instructions. The higher torque performance, stiffer distal ends, and / or higher advancement force may present a higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use.
Please refer to the indication on the label and the Instructions for Use to confirm the appropriate vasculature that this guide wire may be used in. Failure to abide by the above recommendation may result in size mismatch of blood vessel and guide wire, which can result in vessel injury, such as, but not limited to, perforation, dissection, rupture, and avulsion.
Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement. It is recommended that the user determine the source of resistance, exercise caution when removing the device and / or other components as a unit, and exchange the device for a new one to complete the procedure.
Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.
Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object. Manipulation, advancement, and / or withdrawal through a metal device may result in destruction and / or separation of the outer coating, which may cause coating material to remain in the vasculature. This in turn may lead to unintended adverse events requiring additional intervention.
After use, this product may be a potential biohazard. Handle and dispose of it in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
CAUTION: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
When wet, a hydrophilic coating increases the lubricity of the guide wire surface.
Do not soak the device for longer than 4 hours when the device is not in use. Avoid pre-soaking devices for longer than instructed, as this may impact the coating performance.
Percutaneous transluminal angioplasty (PTA) should only be performed at centers where emergency peripheral artery bypass surgery is available.
This guide wire family has distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessels, observing the information in these instructions. The higher torque performance, stiffer distal ends, and / or higher advancement force may present a higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.
The coating swells when exposed to aqueous media, but does not have any impact on device use.
The user and / or patient should report any serious incident that has occurred in relation to the Hi-Torque Proceed™ Guide Wire to the manufacturer and the competent authority of the European Member State in which the user and / or patient is established.
The integrity and performance of the device coating can be negatively impacted by preparation with incompatible media or solvents. Please take note of the following important recommendations:
Attempting to alter the shape of devices by bending, twisting, or similar methods beyond instructed methods may compromise the coating integrity, and that damage to the coating may not always be noticeable to the naked eye.
Potential adverse events associated with use of this device may include the following but are not limited to:
MAT-2007522 v2.0
This Hi-Torque guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
Not intended for use in the cerebral vasculature or with atherectomy devices.
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.
Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.
Do Not:
Do:
For Winn™ family only: The Winn™ family of guide wires have distal ends of varying stiffness. Operate these guide wires carefully so as not to injure the blood vessel, observing the information in these instructions. The higher torque performance, stiffer distal ends, and / or higher advancement force may present a higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use.
Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.
Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.
Hi-Torque Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.
Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.
MAT-2306605 v1.0
All Hi-Torque Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
Hi-Torque Guide Wires are not intended for use in the cerebral vasculature.
This device is designed and intended for ONE-TIME USE ONLY. DO NOT RESTERILIZE AND / OR REUSE.
Observe guide wire movement in the vessels. Before a guide wire is moved or torqued, the tip movement should be examined under fluoroscopy. Do not torque a guide wire without observing corresponding movement of the tip; otherwise, vessel trauma may occur. In addition, during catheter manipulations, ensure that the distal guide wire tip is visible.
Torquing a guide wire against resistance may cause guide wire damage and / or guide wire tip separation. Always advance or withdraw the guide wire slowly. Never push, auger, withdraw or torque a guide wire, which meets resistance. Resistance may be felt and / or observed under fluoroscopy by noting any buckling of the guide wire tip. If guide wire tip prolapse is observed or used for positioning, do not allow the tip to remain in a prolapsed condition; otherwise, damage to the guide wire may occur. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.
If the guide wire tip becomes entrapped within the vasculature, DO NOT TORQUE THE GUIDE WIRE.
Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and not against the vessel wall. Failure to do so may result in vessel trauma upon guide wire exit of the device. Use the radiopaque marker of the interventional device to confirm position.
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use.
Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.
Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.
Hi-Torque Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire in a metal cannula or sharp-edged object.
Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.
MAT-2306606 v1.0
Hi-Torque Supra Core™ 35 Guide Wires are intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures.
Refer to the device label for any additional product specific indications which may apply.
The Hi-Torque Supra Core™ 35 Guide Wire is not intended for use in the cerebral vasculature. Refer to the device label for any additional product specific contraindications which may apply.
This device is designed and intended for ONE TIME USE ONLY. DO NOT RESTERILIZE AND / OR REUSE. Observe all guide wire movement in the vessels. Before a guide wire is moved or torqued, the tip movement should be examined under fluoroscopy. Do not torque a guide wire without observing corresponding movement of the tip; otherwise, vessel trauma may occur.
Torquing a guide wire against resistance may cause guide wire damage and / or guide wire tip separation. Always advance or withdraw the guide wire slowly. Never push, auger, withdraw or torque a guide wire which meets resistance. Resistance may be felt and / or observed under fluoroscopy by noting any buckling of the guide wire tip. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.
If the wire tip becomes entrapped within the vasculature, DO NOT TORQUE THE GUIDE WIRE.
Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform all exchanges slowly to prevent air entry and / or trauma. Wipe the wire before all exchanges.
When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and not against the vessel wall. Failure to do so may result in vessel trauma upon guide wire exit of the device. Use the radiopaque marker of the interventional device to confirm position.
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged wires. Using a damaged wire may result in vessel damage and / or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use.
Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.
Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism, and infection.
MAT-2306103 v1.0
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