Argon Atrieve Vascular Snare-Kit Bedienungsanleitung

ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road Athens, Texas 75751 USA
Tel: 800-927-4669;
Tel: +1 903-675-9321
www.argonmedical.com
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Atrieve™ Vascular Snare Kit
Indication for Use:
The Atrieve™ Vascular Snare Kit is intended for use in the cardiovascular system or hollow viscous
to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous
catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access
veni-puncture procedure assistance.
Description:
The Atrieve™ Vascular Snare Kit comprises a Snare device with three preformed loops constructed of
super-elastic nitinol and platinum. The loops are non-interwoven and can slide relative to one another.
The loops of the Snare can be introduced into a delivery catheter without the risk of permanent device
deformation. The Atrieve™ Vascular Snare Kit also includes a Delivery Catheter, a torque handle, and
an Introducer. The Delivery Catheter has a radiopaque marker band at the distal tip. The product comes
packaged in a protective hoop holder.
The Atrieve™ Vascular Snare Kit is available in the following sizes:
Snare Snare
Diameter Range Length
2-4 mm 175 cm
4-8 mm 175 cm
6-10 mm 120 cm
9-15 mm 120 cm
12-20 mm 120 cm
18-30 mm 120 cm
27-45 mm 120 cm
Warnings:
1. This device is not intended for the removal of foreign objects entrapped by tissue growth.
2. This device should not be used for fibrin sheath stripping in the presence of septal defects of
Persistent Foramen Ovale.
3. This device is not intended for removal of implanted pacing leads.
4. Pull forces applied to catheters during fibrin sheath stripping may damage, stretch, or break
indwelling catheters 6 French or smaller in diameter. Do not use excessive pull force when
attempting fibrin sheath stripping of catheters 6 French or smaller in diameter.
5. Do not use excessive force when manipulating the catheter through an introducer. Excessive
force may damage the catheter.
6. This device was designed, tested and manufactured for single patient use only. Reuse or
reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing
and/or resterilization of this device may create the risk of contamination and patient infection.
Do not reuse, reprocess or resterilize this device.
7. Nitinol is a nickel titanium alloy. Possible reaction may occur for those patients who exhibit
sensitivity to nickel.
8. Possible reaction may occur for those patients who exibit sensitivity to platinum.
Precaution:
1. Care should be observed when using this device for removal of a large fibrin sheath in order to
minimize risk of pulmonary embolism.
2. Bleeding may occur through the delivery catheter hub during some procedures. A hemostasis
valve (not included) can be attached to the delivery catheter to reduce the bleeding as needed or
per physician's judgment.
Potential Complications:
1. Potential complications associated with foreign body retrieval devices in arterial vasculature
include, but are not limited to:
 Embolization
 Stroke
 Myocardial infarction (depending upon placement)
2. Potential complications associated with foreign body retrieval devices in venous vasculature
include, but are not limited to:
 Pulmonary embolism
3. Other potential complications associated with foreign body retrieval devices include, but are
not limited to:
 Vessel perforation
 Device entrapment
Catheter damage can occur when attempting fibrin sheath stripping on small French size diameter
catheters (See WARNINGS). Incidence of pulmonary embolism after fibrin sheath stripping may
occur (See PRECAUTION).
Prepare the Snare:
Select the appropriate Snare diameter range for the site in which the foreign body is located. The
Snare diameter range should approximate the size of the vessel in which it will be used.
1. Remove the Snare and Delivery Catheter components of the kit from their hoop holders and
inspect for any damage.
2. Remove the Introducer and Torque Handle device from the proximal end of the Snare shaft.
3. Load the Snare into the Delivery Catheter by inserting the proximal end of the Snare into the
distal (non-hubbed) end of the Delivery Catheter, until the proximal end of the Snare shaft
exits the hub and the loops can be retracted into the distal end of the Delivery Catheter.
4. Test and inspect the Snare device by extending and retracting the loops through the distal end
of the Catheter 2-3 times, while carefully examining the Delivery Catheter, radiopaque band
and the device for any damage or defects.
5. When appropriate, the Snare and Catheter can be advanced to the desired site as a single
unit assembled as described above.
2797
Delivery Catheter
Size Length
3.2 F 150 cm
3.2 F 150 cm
6 F 100 cm
6 F 100 cm
6 F 100 cm
7 F 100 cm
7 F 100 cm
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Alternative Preparation of the Snare
If the Delivery Catheter is already positioned within the vasculature, the provided
Introducer (located on the proximal end of the Snare and just distal to the Torque Handle) may
be used to position the Snare in the indwelling Delivery Catheter.
1. Remove the Snare from the hoop holder and inspect for any damage.
2. Move the provided Introducer (located on the proximal end of the Snare, just distal to the
Torque Handle) distally until the loops of the Snare are enclosed within the tubing portion of
the Introducer.
3. Insert the distal end of the Introducer into the hub of the indwelling Delivery Catheter until
resistance is felt. This will indicate the tip of the Introducer is properly aligned with the inner
lumen.
4. Hold the Introducer as straight as possible, grasp the shaft of the Snare just proximal to the
hub of the Introducer and advance the Snare until it is secure within the lumen of the
Delivery Catheter. The Introducer can be removed by first removing the Torque Handle and
pulling the Introducer off the proximal end of the Snare's shaft. After removing the
Introducer, re-apply the Torque Handle onto the shaft.
Snare Assisted Retrieval and Manipulation Suggestions:
1. If present, remove the indwelling delivery catheter.
2. If a guidewire is in a patient at the location of a foreign body, advance the Delivery Catheter
over the guidewire to the desired location. Then remove the guidewire and advance the
Snare through the Delivery Catheter. Alternatively, cinch one loop of the Snare over the
proximal end of the guidewire and advance the Snare and Catheter assembly into a guide
catheter or introducer sheath until the distal end of the Delivery Catheter is positioned
proximal to the foreign body.
3. If a guidewire is not present, pull the Snare into the distal end of the Delivery Catheter and
advance through a guide catheter or introducer sheath (not included) until it is positioned
proximal to the foreign body. Alternatively, collapse the Snare loops by pulling the device
into the distal end of the Introducer. Place the tapered end of the Introducer into the
proximal (hub) end of the Delivery Catheter, guide catheter or sheath and advance the
Snare forward maintaining constant contact between the Introducer and Delivery Catheter
hub.
NOTE: When attempting to utilize guide catheters or sheaths not specifically manufactured
for use with the Atrieve™ Vascular Snare, it is important to test product compatibility prior to
use.
4. Gently push the Snare shaft forward to completely open the loops outside of the Delivery
Catheter. The loops are then slowly advanced forward, and may be rotated if desired,
around the proximal end of the foreign body. Alternatively, the Snare may be advanced
beyond the target location and the loops brought back around the distal end of the foreign
body.
5. By advancing the Delivery Catheter, the loops of the device are closed to capture the
foreign body. (Note that attempting to close the loops by pulling the Snare into the Delivery
Catheter will move the loops from their position around the foreign body.)
6. To manipulate a foreign body, maintain tension on the Delivery Catheter to retain the hold
on the foreign body, and move the Snare and Delivery Catheter together to manipulate a
foreign body to the desired position.
7. To retrieve a foreign body, maintain tension on the Delivery Catheter and move the Snare
and Delivery Catheter assembly together proximally to, or into a guide catheter or sheath.
The foreign body is then withdrawn through or together with the guiding catheter or
introducer sheath. Withdrawal of large foreign bodies may require the insertion of larger
sheaths, guiding catheters, or a cut-down at the peripheral site.
Snare Assisted Removal of Fibrin Sheaths from Indwelling Catheters:
1. Using standard technique, prepare a femoral vein approach, advance the selected Snare to
the inferior vena cava or right atrium.
2. Advance a 0.035" guidewire through the end port (distal or venous port if more than one
lumen) of the indwelling catheter and into the inferior vena cava or right atrium.
3. Position one of the Snare loops around the guidewire.
4. Advance the Snare over the distal end of the indwelling catheter to a position proximal to
the fibrin sheath.
5. Close the Snare around the indwelling catheter and continue applying light traction while
gently pulling the Snare down toward the distal end of the indwelling catheter over the end
ports.
6. Repeat steps 4 & 5 until the indwelling catheter is free of fibrin sheath.
Snare Assisted Venous Canalization:
1. Introduce the Snare at a patent venous access site and position in the vasculature at the
desired site.
2. Open the Snare loops to provide a target to guide an entry needle into the desired venous
access site.
3. Introduce a guidewire through the needle and through the Snare loops. Remove the needle.
4. Close the Snare over the guidewire by advancing the Delivery Catheter.
5. Pull the guidewire into the desired location.
How Supplied
The Atrieve™ Vascular Snare Kit is sterilized by ethylene oxide gas. Content is sterile and non-
pyrogenic in unopened and undamaged package. Do not use device if package has been
damaged or has been opened.
Storage
Store in a cool, dry place.
Disposal
After use the Atrieve™ Vascular Snare Kit may be potential biohazard. Handle and dispose of in
accordance with accepted medical practice and all applicable laws and regulations.
Atrieve TM Vascular Snare is a trademark of Argon Medical Devices, Inc.
©2013 Argon Medical Devices, Inc.. All rights reserved.
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