Peripheral Guide Wires

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:

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.
 

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:

• Avoid wiping the device with dry gauze as this may damage the device coating.
• Avoid excessive wiping of the coated devices.
• Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could negatively affect the safety and performance of the guide wire.

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:

• Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials, and drug reactions to anticoagulation, or antiplatelet drugs
• Vascular access complications which may require transfusion or vessel repair, including:
  • Bleeding (ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage)
  • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, and laceration
  • Embolism (air, tissue, plaque, thrombotic material, or device)
• Target artery complications which may require additional intervention, including:
  • Total occlusion or abrupt closure
  • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture
  • Embolism (air, tissue, plaque, thrombotic material, or device)
  • Artery or stent thrombosis
  • Stenosis or restenosis
  • Vessel spasm
  • Claudication
• Venous thromboembolism (including pulmonary embolism)
• Hypotension / hypertension
• Peripheral nerve injury, neuropathy
• Other ischemic conditions / infarct
  • Tissue / organ ischemia
  • Tissue necrosis
  •  Ulcer
  • Acute limb ischemia
• Infection – local and systemic (including post-procedural)
  • Abscess
  • Sepsis / infection including bacteremia / cellulitis / septicemia
• Contrast-induced renal insufficiency or renal failure
• Death