Agilis NxT

Agilis™ NxT Steerable Introducer, Dual-Reach™

Rx Only. Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.

United States: Required Safety Information

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

Rx Only. Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.

United States: Required Safety Information

Indications:
The Agilis™ NxT Steerable Introducer 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:

• Previous intra-atrial septal patch
  
• Known or suspected atrial myxoma or intracardiac thrombus
• Presence of any condition that precludes appropriate vascular access
• Patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
• Patients with an active systemic infection

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 and 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 re‑sterilize 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, withdraw components, and exchange catheters slowly to minimize the risk of air emboli.
• Aspirate all air before fluid infusion from the sideport.
• In order to minimize embolic risk, either provide a continuous infusion of heparinized solution or periodically aspirate and flush through the sideport while the introducer is positioned in the vasculature.
• Fibrin may accumulate in or on the introducer tip during the procedure.To prevent dislodgement of potential thrombus, aspirate when removing the 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.
• 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. 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®)
  • Polyetrafluoroethylene
  • ABS
  • Silicone rubber
  • DOW Corning® 360 Medical Fluid
  • HDPE
  • MDX/hexane solution
  • Nylon

Precautions:

• Federal law (U.S.) restricts this device to sale by or on the order of a physician.
• 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 Agilis™NxT steerable introducer is designed to interlock only with Abbott Medical dilators. Misuse may result in serious complications.
• Do not attempt to use a guidewire larger than the maximum diameter specified on the package label.
• Before inserting the device into the patient, pre-assemble the steerable introducer and the dilator.
• During insertion, do not create excessive bends in the device. This may inhibit advancement of the needle and may result in inadvertent needle puncture of the dilator/introducer assembly.
• Do not remove the dilator or catheter rapidly. Damage to the hemostasis valve may occur.
• Do not deflect the device beyond 180° before insertion of a catheter.
• If resistance is met when advancing or withdrawing the guidewire or the introducer, determine and correct the cause before continuing with this procedure.
• Do not torque or rotate the handle if the distal tip/shaft is constrained.
• If the shaft is unable to rotate freely, only manipulate the introducer via the articulation knob.
• Only aspirate (slowly) from the sideport.
• Only inject or saline flush from the sideport.
• Conditions requiring 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).
• If pericardial or aortic entry occurs, do not advance the dilator over the needle. If the needle has penetrated the pericardium or aorta, it must be withdrawn. Monitor vital signs closely.
• There is a risk of air infiltration when withdrawing objects from the hemostasis valve of the introducer. To prevent vacuum buildup in the introducer, withdraw objects slowly. Monitor the introducer fluoroscopically for the presence of air during device insertion.
• Only use this device with equipment that complies with international safety standards.
• Advance the introducer under fluoroscopic guidance to minimize the risk of cardiac damage, perforation, or tamponade. Compatible navigation and real time visualization systems may also be considered.
• Before advancing the dilator or any other component, verify that the hemodynamics are acceptable. Monitor the hemodynamics throughout the procedure.
• Only use a curved needle with a stylet, such as the BRK™ Transseptal Needle.
• During insertion, check for excessive resistance as the tip of the needle advances through the curvature of the introducer/dilator assembly. If there is any resistance to needle advancement, retract the needle and inspect the components.
• During insertion, always use the stylet to facilitate needle passage through the dilator/introducer assembly. Failure to use the stylet may inhibit advancement of the needle and result in inadvertent puncture of the dilator/introducer assembly or skiving of material from the inner surface of the dilator.
• After the introducer is inserted into the vasculature and the dilator is removed, aspirate until steady blood return is observed before flushing or infusion.
• Do not manipulate the introducer in the heart without a device extending from its distal tip.
• During preparation and assembly of equipment, close the introducer stopcock immediately after flushing the dilator and introducer to prevent air from being introduced into the system.
• To prevent cardiovascular injury, ensure the needle and stylet remain inside the dilator until ready to puncture the atrial septum.
• To remove any air from the needle, remove the stylet from the needle, flush the needle with heparinized saline, and reinsert the stylet.
• During equipment assembly and introducer advancement, insert the dilator fully into the introducer to prevent an air embolism.
• Upon guidewire removal, aspirate air and confirm backflow of blood before flushing with heparinized saline.
• Identify anatomic landmarks correctly to avoid cardiac injury. Individual patient anatomy and physician technique may require procedural variations.
• Prevent any movement of the assembly parts relative to each other. It is critical to maintain previous orientation of the pointer flange while dragging the assembly.
• Confirm the correct location of the needle on the fossa ovalis and then advance the needle carefully.
• Do not attempt to recross the septum without using the needle when access is lost. Only withdraw the needle and introducer/dilator after confirming insertion in the left atrium.
• Introducer materials are incompatible with magnetic resonance imaging (MRI).
• After use, classify this device, its accessories, and packaging for disposal appropriately (example: biohazard, sharps, non-hazardous waste, and so forth). Dispose of the device, its accessories, and packaging in compliance with facility procedures and applicable laws and regulations.