En: Instructions For Use - Amplatzer TorqVue 2 Delivery Sheath Instrucciones De Uso

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AMPLATZER

en: Instructions for Use

Device Description
The AMPLATZER TorqVue 2 Delivery Sheath is designed to provide a pathway through which
a device may be delivered.
The delivery sheath consists of 2 components:
• The single lumen sheath is radiopaque for visibility under fluoroscopy.
• The dilator eases penetration of tissue and facilitates passage of the sheath through the
vessel to the intended site.
Refer to the table and figure on the foldout of the back cover for more information about this
delivery sheath. Sheath dimensions are provided in table T1. The following components are
identified in figure F1.
A. Sheath
B. Dilator
Indications and Usage
The AMPLATZER TorqVue 2 Delivery Sheath is intended to provide a pathway through which
devices are introduced within the chambers and coronary vasculature of the heart or in the
peripheral vasculature.
Contraindications
None known.
Warnings
• Do not use the sheath or dilator if the packaging sterile barrier is open or damaged.
• Use on or before the last day of the expiration month noted on the product packaging.
• Do not use a power injection syringe to inject contrast solution through the sheath.
• The device is sterilized using ethylene oxide and is for single use only. Do not reuse or
resterilize. Attempts to resterilize the device may result in device malfunction, inadequate
sterilization, or patient harm.
• Remove the dilator and sheath from the patient slowly to prevent an ingress of air.
Precautions
• Use standard transcatheter techniques when using AMPLATZER products.
• This delivery sheath 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 sheath.
• 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
sheath.
• Use caution when advancing the dilator and sheath to avoid damaging tissue and vessels
or interfering with previously implanted medical devices.
• Prolonged procedures may result in increased exposure to anesthesia, contrast media,
and/or radiation.
Potential Adverse Events
Potential adverse events that may occur during or after a procedure using this device include,
but are not limited to air embolism, arrhythmia, bleeding, cardiac tamponade, death, fever,
foreign material embolic event, hemodynamic compromise, infection, myocardial infarction,
peripheral embolism, peripheral pulse loss, stroke, thrombus formation, tissue trauma/damage,
transient ischemic attack, valve damage, vascular access site complications, vessel trauma/
damage.
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TorqVue 2 Delivery Sheath
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