Contraindications - Merit Medical Go2wire Mode D'emploi

Guide Wire Extension
I N S T R U C T I O N S F O R U S E
DESCRIPTION:
The GO2WIRE™ Guide Wire extension device is a PTFE* coated
stainless steel guide wire attachment that is 0.035" (0.089 cm) in
diameter and 155 cm length. The extension device has a 152.5
cm long coating of white PTFE shrink tube. The non-coated
stainless-steel attachment section is 2.5 cm in length. It is
compatible with the shorter length (145cm & 175cm) GO2WIRES
that have been modified for attachment to the extension device.
* Polytetrafluoroethylene (PTFE), a synthetic polymer which has
lubricious properties.
INDICATIONS FOR USE:
The extension device is intended, when attached to the guide
wire, to provide enough additional length to the original guide
wire to allow catheter exchanges while maintaining position of the
guidewire in the vasculature.
Carefully read all instructions prior to use. Observe all
warnings and cautions noted throughout these instructions.
Failure to do so may result in complications.

CONTRAINDICATIONS:

No known contraindications. Warnings and intended use of
guidewires and interventional devices compatible with the GO2
Wire™ extension are described in the instructions supplied with the
respective device.
POTENTIAL COMPLICATIONS:
Potential complications which may result from the use of the device
include but are not limited to:
1. Refer to original guide wire instructions for use for potential
complications of wire usage.
2. Separation of the extension device from the guide wire body
3. Potential loss of wire tip position in the vasculature
4. Other potential access site complications leading to bleeding,
dissection, or perforation that may require intervention.
INSPECTION PRIOR TO USE:
Product is sterile if package is unopened and undamaged. Prior to
use, carefully examine all devices to verify that the sterile package
or product has not been damaged in shipment. Prior to and during
use, inspect the guidewire and extension device carefully. Do not
use a damaged device.
PRIOR TO USE:
CAUTION:
1. The physician should be trained with the use of angiography
and angioplasty products and the potential procedural
complications.
2. Confirm the compatibility of the extension wire with other
interventional devices being used by testing the systems
for any resistance prior to actual use. Free movement of the
extension wire within the interventional device must be
confirmed and maintained.
3. The extension wire should be completely hydrated with saline
or heparinized saline prior to removal from the flush dispenser
hoop
NOTE: Distal tip of extension wire may be positioned inside
the dispenser hoop to protect the extension wire sleeve.
4. C AUTI O N: T h e s af e t y an d e f f e c ti ve n ess of th e G o2
steerable wire has not been established in the Coronary or
Neurovasculasture
5. WARNING: Preclinical testing with this device showed the
potential for clot formation in the absence of anticoagulation.
Appropriate anticoagulation therapy should be considered to
reduce the potential for thrombus formation on the device.
GUIDE WIRE EXTENSION DEVICE PREPRATION:
1. Employ aseptic technique during removal from the package
and use.
2. Remove the extension wire retaining J straightener from the
dispenser hoop to expose the extension wire sleeve.
3. Attach flush solution filled syringe to flush dispenser hoop
luer.
4. Inject saline until dripping out opposite end to completely fill
the dispenser hoop.
5. Detach syringe from flush dispenser hoop luer
6. Inspect, prepare, and flush associated device(s) to be used
according to the manufacturer's instructions (If applicable).
N OTE: To reduce the potential of clot formation, it is
recommended that the guide wire extension device be
flushed with saline or heparinized saline prior to use.
DIRECTIONS FOR USE:
English
1. Gently position the proximal end of the guide wire into the
threaded extension wire sleeve.
2. Rotate the extension wire sleeve clockwise approximately 3 to
5 rotations until the extension device feels secure to the wire.
NOTE: Extension device is fully threaded when the extension
portion contacts the white guide wire jacket.
3. Test connection security by grasping the wire and the
extension device on each side of the joint and gently pulling
to confirm secure connection.
4. Prepare the exchange catheter as directed in the device
instructions for use. Withdraw the previously inserted catheter
over the extended guide wire.
5. Examine connections to confirm integrity of the joint
connection and confirm wire tip position in the vasculature
under fluoroscopy before advancing another catheter.
6. Load and advance the catheter onto the proximal end of the
guide wire extension device maintaining position of the guide
wire tip and catheter under fluoroscopy.
7. When exchange is completed, remove the extension device.
Gently grasp the extension wire sleeve and turn counter-
clockwise 3 to 5 rotations.
8. Maintaining position of the guide wire in the vasculature,
gently pull the extension portion away from the wire body to
separate the extension device from the wire.
NOTE: Do not torque or manipulate the guide wire extension
device, the extension device does not contain torqueing
abilities like the guide wires. Attempted torqueing only
results in limited maneuverability of the attached guide wire.
The extension device is used for catheter exchanges only.
Torqueing and other manipulations may be resumed after
removal of the extension device from the guide wire.
DISPOSAL: After use, dispose of product and packaging in
accordance with hospital protocol.
: Caution - Federal Law (USA) restricts this device to sale by
or on the order of a physician.
REUSE PRECAUTION STATEMENT:
For Single Patient Use Only. Do not reuse, reprocess or resterilize.
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.
SYMBOL DESIGNATION
Use By: YYYY-MM-DD
Lot Number
Catalog Number
Do Not Re-sterilize
Do Not Use if Package is Damaged
Single Use
Caution: Consult accompanying documents.
Read instructions prior to use.
For electronic copy scan QR code or go to www.
merit.com/ifu and enter IFU ID Number. For
printed copy, call U.S.A or E.U Customer Service.
Sterilized Using Ethylene Oxide
Non-pyrogenic
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