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Adverse Events
Potential adverse events that may occur during or after a procedure using this sheath may include but are not limited to:
Device Compatibility
Refer to the instructions for use provided with the device to determine delivery sheath compatibility.
Directions for Use
Materials recommended for use with the delivery sheath:
• 0.035-inch guidewire
• Hemostasis valve
Procedure
CAUTION: When placing a device using an AMPLATZER™ TorqVue™ Delivery Sheath, refer to the instructions for use
provided with the device.
General instructions for the AMPLATZER™ TorqVue™ Delivery Sheaths are provided below:
1. Select the appropriate AMPLATZER™ TorqVue™ Delivery Sheath for the device that will be introduced through the
sheath.
2. Prepare the components for use:
- Inspect the sterile pouch and verify that it is unopened and undamaged. Do not use the components if the sterile
barrier has been compromised.
- Gently open the sterile pouch and inspect the components for damage. Do not use damaged or kinked components.
- Flush the components with sterile saline.
- Wipe the sheath and dilator with sterile gauze dampened with sterile saline to remove any foreign material.
3. Insert the dilator into the sheath. You may encounter resistance as the dilator reaches the distal end of the sheath
because the tip of the sheath is tapered. Turn the rotating luer on the dilator clockwise to lock the components together.
4. Place a 0.035-inch guidewire according the device’s instructions for use.
5. Advance the sheath and dilator over the guidewire.
6. Turn the rotating luer on the dilator to unlock the components and slowly remove the dilator from the sheath.
WARNING: Remove the dilator slowly to prevent an ingress of air.
7. Remove the guidewire.
WARNING: Connect a hemostasis valve to the sheath after the dilator and guidewire have been removed to prevent
excessive bleeding or air embolism. To ensure component compatibility and correct fit when attaching any components
other than an AMPLATZER™ loader to the 10 Fr, 12 Fr, or 13 Fr delivery sheath, first attach the flush adapter to the
sheath and then connect other components (including the hemostasis valve) to the flush adapter.
8. Deliver the device according the device’s instructions for use.
9. When the procedure is complete, slowly remove the sheath.
WARNING: Remove the sheath slowly to prevent an ingress of air.
Disposal
• The instructions for use are recyclable. Dispose of all packaging materials appropriately.
• Dispose of delivery systems and accessories following standard solid biohazard waste procedures.
• Air embolism
• Myocardial infarction/ischemia
• Allergic reaction/toxic effects (due to anesthesia, contrast
media, etc.)
• Perforation
• Arrhythmia
• Pericardial effusion
• Bleeding
• Peripheral embolism
• Death
• Stroke
• Dissection
• Thrombus
• Foreign material embolus
• Transient ischemic attack
• Hemodynamic compromise
• Valve damage
• Infection
• Vascular access site injury (e.g., arteriovenous fistulae,
hematoma, pseudoaneurysm)
