Contraindications - Merit Medical Inqwire Gebrauchsanweisung

D i a g n o s t i c G u i d e Wi r e s
I N S T R U C T I O N S F O R U S E
DESCRIPTION
Merit Medical guide wires are fabricated from high quality stainless
steel utilizing a sophisticated construction process and are
available with or without a PTFE coating. Guide wires are supplied
sterile, non-pyrogenic, and are intended for single use only.
Merit Medical guide wires are packaged in a plastic hoop, which
is fitted with a luer hub. This packaging is provided to facilitate
compliance with the manufacturer recommended guidelines that
the wire be flushed with saline or heparinized saline prior to use
(See directions for use - Note).
INDICATIONS
Merit Medical guide wires are used to facilitate the placement of
devices during diagnostic and interventional procedures.

CONTRAINDICATIONS

InQwire diagnostic guide wires, are contraindicated for use in the
coronary and cerebral vasculature.
POTENTIAL COMPLICATIONS
Potential complications which may result from the use of the device
include but are not limited to: Air Embolism/Thromboembolism,
Allergic Reaction, Cardiac Arrhythmia, Amputation, Arteriovenous
(AV) Fistula, Breathing Difficulty, Death, Embolism, Hematoma,
Hemorrhage, Hemoglobinuria, Infection or Sepsis/Infection,
Myocardial Ischemia and/or Infarc tion, Pseudoaneur ysm,
Stroke (CVA)/Transient Ischemic Attacks (TIA), Thrombus, Vessel
Occlusion, Vessel Perforation, Vessel Dissection, Vessel Trauma or
Damage, Vessel Spasm, Wire Entrapment/Entanglement, Foreign
body/Wire Fracture. Some of the stated potential adverse events
may require additional surgical intervention.
PRECAUTIONS
Angiography should be undertaken only by an experienced
angiographer.
FOR ONE TIME USE ONLY
Guide wires will collect blood and other foreign material in
their lumens; neither autoclaving nor ultrasonic cleaning will
completely remove foreign material, therefore guide wires are
recommended for one-time use.
Inspect all guide wires prior to use. Do not use any unit if the
package is open or damaged.
Employ an aseptic technique during removal from the package
and during use.
All guide wires are secured in the hoop dispenser by the locking
J-tip straightener. To avoid damaging the guide wire during
removal from the flush hoop, grasp the J-tip straightener near
the base and slide it forward approximately 5mm or until the
J-tip straightener is no longer attached to the flush hoop adaptor.
Holding both the guide wire and J-tip straightener, continue to
dispense guide wire from the hoop.
Do not use excessive force to advance the moveable core while
the guide wire is in a vessel. Advancement with excessive force
may cause coil penetration and vessel damage. Never push, auger,
or withdraw a guidewire which meets resistance as the could
potentially affect other indwelling devices.
English Avoid withdrawing PTFE coated guide wires back through a metal
needle. The sharp edge of the needle may scrape the coating. It is
suggested that a catheter or PTFE vessel dilator replace the needle
as soon as the guide wire has reached the appropriate position.
During advancement of the catheter and guide wire within the
aorta, it is recommended that the guide wire be removed at the
appropriate level of the aorta.
Care should be taken when manipulating a catheter during
placement and withdrawal to prevent possible intravascular tissue
damage. If resistance is felt during advancement, manipulation
or removal from the catheter, stop immediately and confirm the
guide wire tip position under fluoroscopy. Note proximity of other
potential indwelling devices within the patient's anatomy. Never
push, auger, or withdraw a guidewire which meets resistance as
this could potentially affect other indwelling devices. Resistance
may be felt tactilely or noted by tip buckling during fluoroscopy.
A guide wire is a delicate instrument and remains the most fallible
instrument used in a percutaneous procedure. Any time that a
guide wire is used there is a possibility of thrombus formation/
emboli, vessel wall damage, and plaque dislodgement, which
could result in myocardial infarction, cardiac arrhythmia, stroke or
death. The physician should be familiar with the use of angiography
products and the literature concerning the complications of
angiography.
In the EU, any serious incident that has occurred in relation to the
device should be reported to the manufacturer and the competent
authority of the applicable Member State.
FLUSH HOOP INSTRUCTION GUIDE
1. Attach flush filled syringe to flush port luer
2. Rotate syringe clockwise (as pictured)
3. Inject saline into hoop
4. Detach syringe from hoop
5. Dispense guide wire
Note: In order to reduce the potential of clot formation, it is
recommended that the guide wire be flushed with saline or
heparinized saline prior to use. Attach a filled syringe to the luer
hub located at the end of the plastic hoop, flush several times.
After flushing, remove guide wire from hoop and use as described
above.
DIRECTIONS FOR USE
NOTE: Confirm guide wire and needle compatibility prior to use.
T he following schematic shows a t y pical pro ce dure for
percutaneous entry utilizing the Seldinger technique. Variations
in individual patient anatomy may preclude the utilization of this
technique.
PACKAGED POSITION
FLUSHING POSITION