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Warnings
• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to
resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
• Do not use this device if the sterile package is open or damaged.
• The delivery sheath is designed to be used with the loader. Do not attach a syringe directly to the delivery sheath because
the luer is incompatible and may result in ingress of air or excessive bleeding.
• Use the hemostasis valve to impede the backflow of blood during the implant procedure.
• Do not use a power injection syringe to inject contrast solution through the delivery sheath.
Precautions
• This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should
determine which patients are candidates for procedures that use this device.
• The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs
before, during, and/or after the use of this exchange system.
• Use on or before the last day of the expiration month that is printed on the product packaging label.
• Use caution when advancing the sheath and dilator to avoid damaging tissue and vessels or interfering with previously
implanted medical devices.
• Store in a dry place.
Potential Adverse Events
Potential adverse events that may occur during or after a procedure using this exchange system may include, but are not limited
to:
• Air embolism
• Arrhythmia
• Arteriovenous fistulae
• Bleeding at the access site
• Brachial plexus injury
• Cardiac tamponade
• Death
• Dissection
• Endocarditis
• Hematoma
Procedure
CAUTION: When placing a device using an AMPLATZER™ TorqVue™ Exchange System, refer to the instructions for use
provided with the device.
General instructions for the AMPLATZER™ TorqVue™ Exchange Systems are provided below.
1. Prepare the exchange system for use:
- Inspect the exchange system sterile pouch and verify that it is unopened and undamaged. Do not use the exchange
system 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 all components with sterile saline.
- Wipe the delivery sheath with sterile gauze moistened with sterile saline to remove any foreign material.
2. If the plastic vise is attached to the original delivery cable, remove the plastic vise.
3. Screw the distal end of the exchange system delivery cable to the proximal end of the original delivery cable.
4. Insert the dilator into the delivery sheath. You may encounter resistance as the dilator reaches the distal end of the
sheath because the last few inches of the sheath are tapered. Turn the rotating luer on the dilator clockwise to lock the
components together.
5. Remove the original delivery sheath from the patient.
6. Advance the exchange system delivery sheath and dilator assembly over the delivery cable until the delivery sheath is
positioned according to the device's instructions for use
CAUTION: If the distal tip of the sheath needs to be advanced into the left atrium of the heart, advance the delivery
sheath and dilator assembly only as far as the vena cava before removing the dilator and purging air from the delivery
sheath.
7. Remove the dilator and allow back-bleeding to purge any air from the delivery sheath.
• Infection
• Myocardial infarction
• Perforation
• Peripheral pulse loss
• Stroke
• Thrombosis
• Valve damage
• Vascular occlusion
• Vessel damage
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