2
• Do not use the delivery system if the packaging sterile barrier is open or damaged.
• The sheath is designed to be used with the loader. Do not attach a syringe directly to the sheath because the sizing 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 sheath.
• Remove the dilator and sheath from the patient slowly to prevent an ingress of air.
Precautions
• Store in a dry place.
• This delivery system should only be used by physicians who have been trained in transcatheter techniques. The physician
should determine which patients are suitable candidates for procedures using this delivery system.
• 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 caution when advancing the dilator and sheath to avoid damaging tissue and vessels or interfering with previously
implanted medical devices.
• Use standard transcatheter techniques when using AMPLATZER products.
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 delivery system are identified in Table 1 and Table 2
.
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
• Myocardial infarction
• Arrhythmia
• Perforation
• Arteriovenous fistulae
• Peripheral embolism
• Bleeding • Peripheral
pulse
loss
• Brachial plexus injury
• Stroke
• Cardiac tamponade
• Thrombosis
• Death
• Tissue trauma/damage
• Dissection
• Valve damage
• Endocarditis
• Vascular occlusion
• Hematoma
• Vessel trauma/damage
• Infection
Table 1. Compatibility Chart for TorqVue 45° Delivery System and AMPLATZER Devices
45° Delivery System Sizes
6 Fr
7 Fr
8 Fr
9 Fr
10 Fr
12 Fr
AMPLATZER Septal (ASD) Occluder
4–10 mm 11–17 mm
18 mm
19 mm
20–24 mm
26–30 mm 32-38 mm
AMPLATZER
Multi-fenestrated ASD (Cribriform)
Occluder
––
––
18 mm
25 mm
30 mm
35 mm
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––
AMPLATZER Muscular VSD Occluder
4–10 mm
12 mm
14 mm
16 mm
18 mm
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––
Table 2. Compatibility Chart for TorqVue 180° Delivery System and AMPLATZER Devices
180° Delivery System Sizes
5 Fr
6 Fr
7 Fr
8 Fr
9 Fr
AMPLATZER Duct (PDA) Occluder
5/4 mm
6/4 mm
8/6 mm
10/8 mm
12/10 mm
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