Abbott AMPLATZER TorqVue Series User manual

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Manufacturing facility:
Abbott Medical
5050 Nathan Lane North
Plymouth, MN
55442 USA
[phone]
[phone]
ARTEN600038212A
2018-09
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective owner.
Pat. http://www.abbott.com/patents
© 2018 Abbott. All Rights Reserved.
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.
TorqVue™ 45° x 45° Delivery Sheath
Instructions for Use

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Adverse Events
Potential adverse events that may occur during or after a procedure using this sheath may include but are not limited to:
Device Compatibility
Refer to the instructions for use provided with the device to determine delivery sheath compatibility.
Directions for Use
Materials recommended for use with the delivery sheath:
• 0.035-inch guidewire
• Hemostasis valve
Procedure
CAUTION: When placing a device using an AMPLATZER™ TorqVue™ Delivery Sheath, refer to the instructions for use
provided with the device.
General instructions for the AMPLATZER™ TorqVue™ Delivery Sheaths are provided below:
1. Select the appropriate AMPLATZER™ TorqVue™ Delivery Sheath for the device that will be introduced through the
sheath.
2. Prepare the components for use:
- Inspect the sterile pouch and verify that it is unopened and undamaged. Do not use the components 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 the components with sterile saline.
- Wipe the sheath and dilator with sterile gauze dampened with sterile saline to remove any foreign material.
3. Insert the dilator into the sheath. You may encounter resistance as the dilator reaches the distal end of the sheath
because the tip of the sheath is tapered. Turn the rotating luer on the dilator clockwise to lock the components together.
4. Place a 0.035-inch guidewire according the device’s instructions for use.
5. Advance the sheath and dilator over the guidewire.
6. Turn the rotating luer on the dilator to unlock the components and slowly remove the dilator from the sheath.
WARNING: Remove the dilator slowly to prevent an ingress of air.
7. Remove the guidewire.
WARNING: Connect a hemostasis valve to the sheath after the dilator and guidewire have been removed to prevent
excessive bleeding or air embolism. 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 delivery sheath, first attach the flush adapter to the
sheath and then connect other components (including the hemostasis valve) to the flush adapter.
8. Deliver the device according the device’s instructions for use.
9. When the procedure is complete, slowly remove the sheath.
WARNING: Remove the sheath slowly to prevent an ingress of air.
Disposal
• The instructions for use are recyclable. Dispose of all packaging materials appropriately.
• Dispose of delivery systems and accessories following standard solid biohazard waste procedures.
• Air embolism • Myocardial infarction/ischemia
• Allergic reaction/toxic effects (due to anesthesia, contrast
media, etc.)
• Perforation
• Arrhythmia • Pericardial effusion
• Bleeding • Peripheral embolism
•Death •Stroke
• Dissection • Thrombus
• Foreign material embolus • Transient ischemic attack
• Hemodynamic compromise • Valve damage
• Infection • Vascular access site injury (e.g., arteriovenous fistulae,
hematoma, pseudoaneurysm)

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Warranty
Abbott Medical warrants to buyer that, for a period equal to the validated shelf life of the product, this product shall meet the
product specifications established by the manufacturer when used in accordance with the manufacturer's instructions for use
and shall be free from defects in materials and workmanship. Abbott Medical's obligation under this warranty is limited to
replacing or repairing at its option, at its factory, this product if returned within the warranty period to Abbott Medical and after
confirmed to be defective by the manufacturer.
EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY, ABBOTT MEDICAL DISCLAIMS ANY REPRESENTATION OR
WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
See the Terms and Conditions of Sale for further information.
State of California (USA) Only:
WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to
cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.
Symbol Definitions
The following symbols may appear on the device packaging:
Symbol Definition
Caution, consult accompanying documents
Manufacturer
Contains phthalate
EU authorized representative
Reference number
Product serial number
Batch code
Unique Device Identification
Use By date (do not use the device after the end of the month shown)
Do not reuse
Sterilized using ethylene oxide
Consult instructions for use
Follow instructions for use on this website
Keep dry

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Do not use if package is damaged
Not made with natural rubber latex
Inner diameter
Outer diameter
Length
Usable length
Recommended delivery sheath/catheter dimensions
Hydrophilic coating
Federal law (USA) restricts this device to sale by or on the order of a physician (or properly
licensed practitioner).
Date of Manufacture
Quantity
Delivery Sheath
ONLY
Delivery Sheath