Stryker Synchro2 Gebrauchsanweisung Seite 3

• Always advance or withdraw the guidewire slowly and carefully. Never
advance, auger, withdraw, or torque a guidewire which meets resistance.
Resistance may be felt and/or observed under fluoroscopy by noting any
buckling or prolapse of the guidewire tip. Excessive force against resistance
may result in damage to the guidewire, such as separation of the guidewire
tip, damage to the interventional device, and/or vessel perforation. Determine
the cause of the resistance under fluoroscopy and take any necessary
remedial action.
• The torque device and the introducer are included to aid in the use of the
guidewire and are not intended to enter the patient's body at any time.
• This device is coated with a hydrophilic coating at the distal end of the device.
For Synchro Soft and Synchro Standard Guidewires, the hydrophilic coating
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length is 50 cm and for the Synchro
refer to Preparations for Use and Instructions for Use Sections for further
information on how to prepare and use this device to ensure it performs
as intended. Failure to abide by the warnings in this labeling might result in
damage to the device coating, which may necessitate intervention or result in
serious adverse events.
PRECAUTIONS
• Confirm the compatibility of the guidewire with the microcatheter before use.
The wire should move freely within the catheter.
• Securely fasten the torque device onto the wire to prevent slippage of the
torque device and to avoid product damage (i.e., core wire abrasion/peeling of
PTFE, etc.)
• Maintain a continuous saline flush between the guiding catheter and
the interventional device and between the interventional device and the
guidewire during the procedure. Flushing prevents contrast crystal formation
and/or clotting on the guidewire and in the catheter lumen.
• Verify that package integrity has not been compromised prior to use. Do not
use a product after the expiration date.
• Inspect the guidewire for any visible damage prior to use, and do not use a
wire that is damaged.
• Carefully examine all equipment for defects prior to the interventional
procedure. Do not use any defective equipment.
• This device requires use under fluoroscopic guidance. Limit the exposure to
X-ray radiation doses to patients and physicians by using sufficient shielding,
reducing fluoroscopy times, and modifying X-ray technical factors when
possible.
• Avoid wiping the device with dry gauze as this may damage the device
coating.
• Avoid excessive wiping of the coated device.
• Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the
device because this may cause unpredictable changes in the coating which
could affect the device safety and performance.
• Avoid pre-soaking devices for longer than instructed, as this may impact the
coating performance.
ADVERSE EVENTS
Clinical complications may result from improper use of the device. Follow
instructions for use carefully. Potential adverse events associated with guidewire
Support Guidewire, it is 51 cm. Please
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use include, but are not limited to:
• aneurysm perforation/rupture
• death
• embolus
• hemorrhage
• infection
• ischemia
• neurological/intracranial sequelae
• pseudoaneurysm
• stroke
• transient ischemic attack
• vasospasm
• vessel trauma, occlusion, perforation, dissection
• other procedural complications including, but not limited to anesthetic and
contrast media risks, hemodynamic compromise, renal insufficiency, access
site complications
Use of device requires fluoroscopy which presents potential risks to physicians
and patients associated with x-ray exposure. Possible risks include, but are not
limited to, the following:
• Alopecia
• Burns ranging in severity from skin reddening to ulcers
• Cataracts
• Delayed neoplasia
Adverse Event Reporting
Any serious product-related incident should be reported to both Stryker
Neurovascular and the competent authority of the European Member State, or
equivalent national authority, where the user and/or patient is established. Please
make every attempt to retain any suspect device, its associated components and
their packaging for return to Stryker Neurovascular.
HOW SUPPLIED
Packaging is designed to maintain sterility according to the expiration date on
the label unless the primary product pouch has been labeled otherwise, opened
or damaged.
Handling and Storage
Store in a cool, dry, dark place.
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
OPERATIONAL INSTRUCTIONS
Preparations for Use
1. Flush packaging coil with heparinized saline solution in order to hydrate the
wire coating. Once the product is hydrated, do not allow the product to dry.
2. Prior to inserting the guidewire into a catheter, flush the catheter with
heparinized saline solution.
3. Carefully remove guidewire from protective packaging coil. Examine prior to
use for evidence of bends, kinks or other damage.
4. Pre-shaped Synchro Guidewires can be used as supplied or re-shaped using
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