2
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.
• 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.
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 judgement in situations that involve the use of anticoagulants or antiplatelet drugs
before, during, and/or after the use of this delivery 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 delivery system may include, but are not limited
to:
Device Compatibility
The AMPLATZER
™
devices compatible with the TorqVue
™
LP delivery system are identified in Table 1.
CAUTION: No devices other than those listed in these tables have been tested for use with the delivery system. Using
untested devices with the delivery system may result in technical failures and/or adverse events.
• Air embolism
• Infection
• Arrhythmia
• Myocardial infarction
• Arteriovenous fistulae
• Perforation
• Bleeding at the access site
• Peripheral pulse loss
• Brachial plexus injury
• Stroke/transient ischemic attack
• Cardiac tamponade
• Thrombosis
• Death
• Valve damage
• Dissection
• Vascular access site injury
• Endocarditis
• Vascular occlusion
• Hematoma
• Vessel damage
• Hemodynamic compromise
Table 1. Compatibility Chart for the TorqVue
™
LP Delivery System and AMPLATZER
™
Devices
Delivery System
Sizes
4 Fr
5 Fr
AMPLATZER
™
Vascular Plug
4 mm
6 mm
8 mm
AMPLATZER
™
Duct Occluder II
03-04 mm
04-04 mm
03-06 mm
04-06 mm
05-04 mm
06-04 mm
05-06 mm
06-06 mm
Table 2. Delivery System Dimensions
Delivery system
(catheter) size
Inner diameter of
delivery catheter
4 Fr
1.17 mm (0.046 in)
5 Fr
1.50 mm (0.059 in)
