2
• Use the hemostasis valves to impede the back-flow of blood during the implant procedure
and minimize the risk of air ingress.
• Do not use a power injection syringe to inject contrast solution.
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 anti-platelet drugs before, during, and/or after the use of this delivery
catheter.
• Use on or before the last day of the expiration month that is printed on the product
packaging label.
• Use caution and rely on imaging guidance when advancing the sheath and dilator to avoid
damaging tissue and vessels or interfering with previously implanted medical devices.
• Store in a dry place.
Adverse Events
Potential adverse events that may occur during or after a procedure using this device may
include, but are not limited to:
• Air embolism
•Arrhythmia
• Arteriovenous fistulae
• Bleeding at the access site
• Brachial plexus injury
• Cardiac tamponade
•Death
• Dissection
•Embolism
• Endocarditis
• Hematoma
• Hemodynamic compromise
• Infection
• Myocardial infarction
• Perforation
• Peripheral pulse loss
• Stroke/transient ischemic attack
• Thrombosis
• Valve damage
• Vascular access site injury
• Vascular occlusion
• Vessel damage
Device Compatibility
Refer to the instructions for use supplied with the device to be implanted to determine catheter
compatibility.
Procedures
1. Prepare the delivery catheter for use:
- Inspect the delivery catheter sterile pouch and verify that it is unopened and
undamaged. Do not use the delivery catheter 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 catheter with sterile gauze moistened with sterile saline to remove
any foreign material.
2. Connect the Tuohy-Borst hemostasis valve to the delivery catheter. Make sure there
are no gaps between the components.
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