Abbott AMPLATZER TorqVue Series Instructions For Use

TorqVue™ 45° x 45° Delivery Sheath
Device Description
The AMPLATZER™ TorqVue™ Delivery Sheath is designed to provide a pathway through which a device may be delivered.
The body of each sheath is radiopaque for visibility under fluoroscopy. The included dilator eases penetration of tissue. The
10 Fr, 12 Fr, and 13 Fr delivery sheaths also include a flush adapter to facilitate attachment of additional device components.
Indications for Use
The AMPLATZER™ TorqVue™ 45° x 45° Delivery Sheath is intended to provide a pathway through which devices are
introduced within the chambers of the heart.
Contraindications
None known.
Warnings
• Do not use this device if the sterile package is open or damaged.
• To ensure component compatibility and correct fit when attaching any components other than an AMPLATZER™ loader to
the 10 Fr, 12 Fr, or 13 Fr sheath, first attach the flush adapter to the sheath and then connect other components (including
the hemostasis valve) to the flush adapter.
• Do not use a power injection syringe to inject contrast solution through this sheath.
• 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.
• Remove the dilator and sheath slowly to prevent an ingress of air.
Precautions
• Use on or before the last day of the expiration month that is printed on the product packaging label.
• This device should be used only by physicians who are trained in transcatheter techniques. The physician should
determine which patients are suitable candidates for procedures using 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 the TorqVue™ Delivery Sheath.
• Use caution when advancing the sheath and dilator 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.
• Store in a dry place.
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‡ Indicates a third party trademark, which is property of its respective owner.
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Instructions for Use
1
ARTEN600038212A
2018-09
Manufacturing facility:
Abbott Medical
5050 Nathan Lane North
Plymouth, MN
55442 USA
+1 855 478 5833
+1 651 756 5833