Merit Medical ONE Snare Endovascular Microsnare System Gebrauchsanweisung Seite 3

M I C R O S N A R E K I T
I N S T R U C T I O N S
DESCRIPTION:
The ONE Snare® Endovascular Microsnare System consists of the snare, snare catheter, insertion
tool and torque device. The microsnare is constructed of nitinol cable and a gold plated tung-
sten loop. The pre-formed microsnare loop can be introduced through catheters without risk of
snare deformation because of the snare's super-elastic construction. The microsnare catheter
is constructed of polyether block amide (Pebax®) and contains a platinum/iridium radiopaque
marker band.
INDICATIONS FOR USE:
The ONE Snare® endovascular microsnare system is intended for use in adult and pediatric
populations for the retrieval and manipulation of atraumatic foreign bodies located in the
coronary and peripheral cardiovascular system and the extra-cranial anatomy.
CONTRAINDICATIONS:
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.
WARNINGS:
1. Do not use excessive force when manipulating the catheter through an introducer.
Excessive force may damage the catheter.
2. This device has been sterilized utilizing ethylene oxide and is considered sterile if the
package is not opened or damaged. Do not use a device that has been damaged or if the
package is open or damaged.
3. For single patient use only. Do not reuse, reprocess or sterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to device
failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing, or
resterilization may also create a risk of contamination of the device and/or cause patient
infection or cross-infection including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to injury,
illness or death of the patient.
4. After use this device may be a potential biohazard. Handle in a manner that will prevent
accidental contamination.
5. Nitinol is a nickel titanium alloy. Possible reaction may occur for those patients who exhibit
sensitivity to nickel.
P x Only: CAUTION - Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician.
POTENTIAL COMPLICATIONS:
1. Potential complications associated with snare retrieval devices in arterial vasculature
include, but are not limited to:
• Embolization
• Stroke
• Myocardial infarction (depending upon placement)
2. Potential complications associated with snare 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
DIRECTIONS FOR USE:
Prepare the ONE Snare® Endovascular Microsnare System:
Select the appropriate microsnare diameter range for the site in which the foreign body is
located. The microsnare diameter range should approximate the size of the vessel in which it
will be used.
1. Remove the microsnare and microcatheter from their hoop holders and inspect for any
F O R U S E :
damage.
2. Remove the insertion tool and torque device from the proximal end of the microsnare shaft.
3. Load the microsnare into the microcatheter by inserting the proximal end of the microsnare
into the distal (non-hubbed) end of the microsnare catheter, until the proximal end of the
microsnare shaft exits the hub and the loop can be retracted into the distal end of the snare
microcatheter.
Alternative Preparation of the ONE Snare® Endovascular Microsnare System:
If the snare microcatheter is already positioned within the vasculature, the provided insertion
tool (located on the proximal end of the microsnare and just distal to the torque device) may be
used to position the microsnare in the indwelling snare microsnare catheter.
1. Remove the microsnare from the protective holder and inspect for any damage.
2. Move the provided insertion tool distally until the loop of the microsnare is enclosed within
the tubing portion of the insertion tool.
3. Insert the distal end of the insertion tool into the hub of the indwelling snare microcatheter
until resistance is felt. This will indicate the tip of the insertion tool is properly aligned with
the inner lumen.
4. Hold the insertion tool as straight as possible, grasp the shaft of the microsnare just proxi-
mal to the hub of the insertion tool and advance the microsnare until it is secure within the
lumen of the microcatheter. The insertion tool can be removed by grasping the blue tab and
firmly peeling it away from the microsnare shaft.
Position Microsnare Proximal to Foreign Body (Microsnare Assembled Outside the Body/
Guidewire Present):
1. Remove the indwelling balloon or delivery catheter, if present. It may be necessary to
change or extend the indwelling guidewire to facilitate balloon removal, and to upsize the
indwelling guide catheter/sheath to accommodate the 2.3-3.0F (0.81-1.0 mm) microsnare
catheter.
2. Place the microsnare loop over the proximal end of the wire, and cinch until just snug by
pulling the proximal end of the microsnare shaft.
3. Advance the microsnare, distal end first, into the guide catheter or sheath until the distal
end of the catheter is positioned just proximal to the foreign body.
Microsnare Assembled Outside The Body/Guidewire Not Present:
1. Pull the microsnare loop just into the distal end of the microcatheter.
2. Advance the microsnare in the guide catheter until it is positioned just proximal to the
foreign body.
Microsnare Assembled With An Indwelling Catheter:
1. Advance the microsnare shaft in the microcatheter until the loop is just proximal to the
microcatheter end hole.
2. Advance the microsnare in the guide catheter until it is positioned just proximal to the
foreign body.
Microsnare Assisted Manipulation/Retrieval:
1. Push the microsnare shaft forward gently to completely open the loop. Slowly advance the
loop forward, and around the proximal end of the foreign body.
2. Once the loop is around the foreign body, advance the catheter to cinch the loop closed and
grab the foreign body. (Note that attempting to close the loop by pulling the microsnare
within the catheter will move the loop from its position around the foreign body.)
3. To manipulate a foreign body, maintain tension on the catheter to retain the hold on the
foreign body, and move the microsnare and microcatheter together to manipulate foreign
body to the desired position.
4. To retrieve a foreign body, maintain tension on the microcatheter and move the microsnare
and catheter together (proximally) to, or into the guide catheter or sheath. The foreign
body is then withdrawn through or together with the guiding catheter or vascular sheath.
Withdrawal of large foreign bodies may require the insertion of larger sheaths, or guiding
catheters, or a cut down at the peripheral site.
ONE Snare® Endovascular Microsnare System contains:
(1) Microsnare, (1) Microsnare Catheter, (1) Insertion Tool and (1) Torque Device.