Agilis NxT

The Agilis™ NxT Steerable Introducer, Dual-Reach™

Indications:

The Agilis™ NxT Steerable Introducer, Dual-Reach™ is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.

Contraindications:

The Agilis™ NxT Steerable Introducer, Dual-Reach™ is contraindicated for:

• Previous interatrial septal patch.
• Known or suspected atrial myxoma. 
• Acute myocardial infarction. 
• Unstable angina. 
• Recent cerebral vascular accident (CVA). 
• Patients who do not tolerate anticoagulation therapy. 
• Patients with an active infection. 
• Presence of an intracardiac thrombus.

Warnings:

Do not alter this device in any way. This device must be used by board-certified electrophysiologists, or EP fellows in training, in a fully-equipped operational EP laboratory. This device is intended for one time use only; do not reprocess or reuse it. Note the product “Use by” date on the package. Any attempt to resterilize and reuse this system may compromise its integrity. Adverse effects of using nonsterile components may include, but are not limited to: Local or systemic infection or reaction, Mechanical damage, Inaccurate functionality. Always aspirate, insert and withdraw components, and exchange catheters slowly to minimize the risk of air emboli. Aspirate all air before fluid infusion from the sideport. Provide continuous heparinized saline infusion while the introducer remains in the vessel. Fibrin may accumulate in or on the introducer tip during the procedure. To prevent dislodgement of potential thrombus, aspirate when removing dilator or catheter. Before removing the steerable introducer, reinsert the guidewire through the introducer, reintroduce the dilator over the guidewire, straighten the steerable introducer, then remove the dilator, guidewire, and introducer as a unit. Maximum in-vivo time: 7 hours. Read the IFU carefully before using this device to help reduce the potential risks and complications associated with the transseptal technique, such as air emboli and perforation of the aorta and left atrium. Aspirate and saline flush the introducer frequently to minimize the potential for thrombus formation. Do not use the introducer without a catheter or dilator supporting the lumen. Use of the introducer directly over a wire without a catheter or dilator supporting the lumen may result in complications that can cause death. For both patients and laboratory staff, cardiac catheterization procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects due to the x-ray beam intensity and duration of the fluoroscopic imaging. Carefully consider the use of this introducer in pregnant women. Persons with known history of allergies to any of the materials listed below may suffer an allergic reaction to this device. Before use, counsel the patient on the materials contained in the device and discuss a thorough history of allergies. This device contains: Polyether block amide (PEBAX), Polytetrafluoroethylene, ABS, Silicone rubber, DOW Corning 360 fluid , HDPE, MDX/hexane solution, Nylon.

Precautions:

Federal law (U.S.) restricts this device to sale by or on the order of a physician. Only use this device with equipment that complies with international safety standards. Store in a cool, dark, dry place. Inspect all components before use. Do not use if the packaging or items in the kit appear to be damaged or defective. Conditions requiring special consideration when using this product may be, but are not limited to, small left atrium, marked right atrial enlargement, and marked distortion of the thorax configuration (example, kyphosis or scoliosis). Individual patient anatomy and physician technique may require procedural variations.

Potential Adverse Events:

The following potential complications may occur during the use of this device, but are not limited to: Arrhythmia. Bleeding Major: bleeding requiring surgery or transfusion, Hematomas or Anemia. Cardiac perforation: Cardiac tamponade, Pericardial complications, Pericardial effusion Hemopericardium, Pneumopericardium, Pericarditis. Cardiovascular injury: Atrial/ventricular trauma, Great vessel perforation, Valvular damage. Cerebral injury: Asymptomatic cerebral emboli (ACE), Stroke/cerebrovascular accident, Transient ischemic attack (TIA). Coronary artery injury. Embolism: Air embolism, Foreign body embolism, Pulmonary embolism, Thromboembolism, Thrombosis/thrombus. Hypotension: Vasovagal reaction. Immunological reaction: Anesthesia reaction, Anaphylaxis. Infection: Endocarditis, Pneumonia, Sepsis/shock. Organ injury: Esophageal injury, Pleural effusion. Pain: Groin. Peripheral vascular injury: Arteriovenous fistula, Dissection, Laceration, Pseudoaneurysm. Superficial tissue injury. Please consult the respective manufacturer's labeling for adverse events associated with the use of either cardiovascular catheters or endomyocardial biopsy devices.

Agilis™ NxT Steerable Introducer

Indications:
The Agilis™ NxT Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Contraindications:
The Agilis™ NxT Steerable Introducer is contraindicated for previous intra-atrial septal patch, Known or suspected atrial myxoma, Myocardial Infarctions within the last two weeks, Unstable angina, Recent Cerebral Vascular Accident (CVA), Patients who do not tolerate anticoagulation therapy, Patients with an active infection, and Presence of atrial thrombus.

Warnings:
Do not alter this device in any way. Only those physicians who are trained in transseptal procedures and Abbott delivery systems should use this device. Do Not reuse this device. Thorough cleaning of biological and foreign material is not possible. Adverse patient reactions may result from reuse of this device. Maintain continuous hemodynamic monitoring throughout procedure. Always observe acceptable hemodynamics prior to advancing the dilator or any other component. Always withdraw components/aspirate slowly to minimize the vacuum created during withdrawal. From the sideport only – aspirate all air prior to fluid infusion. Provide continuous heparinized saline infusion while the introducer remains in the vessel. Fibrin may accumulate in or on the sheath tip during the procedure. To prevent dislodgment of potential thrombus, aspirate when removing dilator or catheter. Prior to removing the steerable introducer, reinsert the guidewire through the introducer, reintroduce the dilator over the guidewire, straighten the steerable introducer, then remove the dilator, guidewire, and introducer as a unit. Maximum in-vivo time: 7 hours.

Precautions:

• Federal law (U.S.) restricts this device to sale by or on the order of a physician.
• Carefully reading the Instructions before use of this device will help to reduce the potential risks and complications associated with the transseptal technique such as air emboli and/or perforation of the aorta and left atrium.
• Inspect all components before use. Do not use if the package or items in the kit appear to be damaged or defective.
• The French size specified represents the inner diameter of the introducer sheath.
• Do not attempt to insert a catheter having a distal tip or body size larger than the introducer size indicated.
• The SJM™ Agilis™NxT steerable introducer is designed to interlock only with SJM™ dilators. Misuse may result in serious complications.
• Do not attempt to use a guidewire larger than the maximum diameter specified on the package label.
• Prior to inserting the device into the patient, pre-assemble the steerable introducer and dilator.
• During insertion, use caution not to create excessive bends in this device.
• Frequently aspirate and saline flush the sheath to minimize the potential for thrombus formation.
• Do not remove dilator or catheter rapidly. Damage to the backbleed valve may occur.
• Do not deflect the device beyond 180◦ prior to insertion of a 8 mm tip electrode catheter.
• If resistance is met when advancing or withdrawing guidewire or introducer, determine cause and correct before continuing with this procedure.
• Do not use the introducer without a catheter or dilator supporting the lumen.
• Use of the introducer directly over a wire without a catheter or dilator supporting the lumen may result in air embolism, which can lead to death.
• Do not torque or rotate the handle if the distal tip/shaft is constrained.
• If the shaft is unable to freely rotate, only manipulate the catheter via the articulation knob.
• Indwelling percutaneous introducers should always be supported with a catheter or dilator.
• Aspirate slowly, only from the sideport.
• Inject or saline flush only from the sideport.
• Certain conditions may require special consideration when using this product. These may be, but are not limited to enlarged aortic root, small left atrium, marked right atrial enlargement, marked distortion of the thorax configuration (i.e. kyphosis or scoliosis).
• Store in a cool, dark, dry place.
• This device is intended for one time use only. Do not reprocess or reuse. Reuse can cause patient injury and/or the communication of infectious disease(s) from one patient to another