AGA Medical AMPLATZER TorqVue User manual

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Manufacturing Facility:
5050 Nathan Lane North
Plymouth, MN 55442 USA
+1.888.546.4407 Toll Free
+1.763.513.9227 Phone
+1.763.513.9226 Fax
www.amplatzer.com
Device Description
The AMPLATZER TorqVue 45° and 180° Delivery Systems are designed to deliver AMPLATZER devices. The device and
delivery system are shipped separately. The body of the sheath is radiopaque for visibility under fluoroscopy.
A. Loader – Introduces an AMPLATZER device into the sheath
B. Hemostasis valve with extension tube and stopcock – Allows flushing of the delivery system and controls blood backflow
C. Sheath – Provides a pathway through which an AMPLATZER device is delivered
D. Dilator – Eases penetration of tissue and minimizes vessel trauma
E. Delivery cable – Attaches to the device to control its movement through the sheath
F. Plastic vise – Attaches to the delivery cable and serves as a handle for disconnecting (unscrewing) the delivery cable from a
device
Indications and Usage
The AMPLATZER TorqVue delivery system 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
• Use on or before the last day of the expiration month noted on the product packaging.
• The delivery system 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.
Figure 1. AMPLATZER TorqVue Delivery System Components
TorqVue
®
45° and 180° Delivery Systems
Instructions for Use
600266-002
11-2009 US
© 2005, 2007–2009 AGA Medical Corporation
AMPLATZER and TorqVue are trademarks of AGA Medical Corporation.
AGA Medical products and technologies for which patents are granted and/or pending in the USA
and/or other countries are listed at www.amplatzer.com/patents
Not in any way connected with medical gas or equipment sold under the “AGA” brand by AGA AB
or its successors.
C
D
EF
AB
*600266-002*

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• 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 –– ––
AMPLATZER Muscular VSD Occluder 4–10 mm 12 mm 14 mm
16 mm 18 mm –– ––
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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Directions for Use
Materials recommended for use with the delivery system
Exchange-length 0.035-inch guidewire
Procedure
CAUTION: Refer to the instructions for use provided with the device when placing an AMPLATZER device using an
AMPLATZER TorqVue Delivery System.
General instructions for the AMPLATZER TorqVue Delivery Systems are provided below.
1. Select the appropriate delivery system for use with the device being delivered. Refer to Table 1 and Table 2 to select a
delivery system by AMPLATZER device size, or refer to Table 3 to select the delivery system with a sheath that has the
correct inner diameter as indicated in the device’s instructions for use.
2. Prepare the delivery system 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 all components with sterile saline.
- Wipe the dilator and sheath with sterile gauze moistened with sterile saline to remove any foreign material.
3. Access the desired vessel.
4. Place the guidewire according to the device’s instructions for use.
5. Insert the dilator into the sheath. You may encounter resistance as the dilator reaches the distal end of the sheath
because the end of the sheath is tapered.
6. Turn the rotating luer on the dilator clockwise to lock the components together.
7. Advance the dilator and sheath over the guidewire until the sheath is positioned according to the device’s instructions for
use.
8. Turn the rotating luer on the dilator counterclockwise to unlock the dilator. Slowly remove the dilator from the sheath.
WARNING: Remove the dilator slowly to prevent an ingress of air.
9. Allow blood backflow to purge any air from the sheath.
10. Attach the hemostasis valve to the proximal end of the loader and flush with sterile saline.
CAUTION: Use the hemostasis valve to impede blood backflow during the implant procedure.
11. Capture the device in the loader according to the device's instructions for use.
12. Attach the distal end of the loader to the proximal end of the sheath. Turn the rotating luer on the loader clockwise to lock
the components together. Remember to close the stopcock on the hemostasis valve.
AMPLATZER Muscular VSD Occluder 4 mm 6–10 mm 12 mm 14 mm
16 mm 18 mm
Table 3. Delivery System Dimensions
Delivery system
(sheath) size
Inner diameter of
sheath
Outer diameter of
sheath
5 Fr 1.83 mm (0.07 in) 2.51 mm (0.10 in)
6 Fr 2.11 mm (0.08 in) 2.79 mm (0.11 in)
7 Fr 2.44 mm (0.10 in) 3.18 mm (0.13 in)
8 Fr 2.69 mm (0.11 in) 3.45 mm (0.14 in)
9 Fr 3.00 mm (0.12 in) 3.81 mm (0.15 in)
10 Fr 3.30 mm (0.13 in) 4.14 mm (0.16 in)
12 Fr 3.99 mm (0.16 in) 4.80 mm (0.19 in)
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

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13. Position, deploy, and detach the device according the device’s instructions for use.
14. When the procedure is complete, slowly remove the sheath.
WARNING: Remove the sheath slowly to prevent an ingress of air.
Disposal
• Dispose of all packaging materials as appropriate.
• Dispose of delivery systems and accessories following standard solid biohazard waste procedures.
Warranty
AGA Medical Corporation 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. AGA Medical Corporation'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 AGA Medical
Corporation and after confirmed to be defective by the manufacturer.
EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY, AGA MEDICAL CORPORATION 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.
Symbol Definitions
The following symbols may appear on the device packaging:
Symbol Definition
Manufacturer
EU authorized representative
Reference number
Product serial number
Product lot number
Use by date
(Use on or before the last day of the expiration month noted on the product packaging.)
Do not reuse
Sterilized using ethylene oxide
Consult operating instructions
Keep dry
Do not use if package is damaged

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Latex free
Inner diameter
Outer diameter
Length
Usable length
Recommended delivery sheath/catheter dimensions
Federal law (USA) restricts this device to sale by or on the order of a physician (or properly licensed
practitioner).
Indication of conformity with the essential health and safety requirements set out in European
Directives