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HYDROPHILIC GUIDE WIRE
INSTRUCTIONS FOR USE
Carefully read all warnings, precautions and directions prior to use. Failure to do so may
result in the improper use of this device which could cause the following complications:
•
Shearing of the hydrophilic guide wire
•
Release of plastic pieces or fragments from the hydrophilic guide wire which may
need to be retrieved from the vasculature.
•
Vessel trauma
DESCRIPTION
Merit Medical hydrophilic guide wires are constructed from a high quality, steerable,
metallic core wire with a polymer coating. The metallic core wire is utilized throughout
the entire length of the wire body. The polymer coating (jacket) extends across the entire
length of the guide wire surface. A hydrophilic coating is applied over the radiopaque
polymer jacket. The hydrophilic coating extends across the entire length of the guide
wire surface. The hydrophilic coating, when activated, provides lubricity across the entire
polymer surface allowing the guide wire to navigate through the vasculature. Guide wires
are supplied sterile and non-pyrogenic.
INDICATIONS FOR USE
The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system
to facilitate the placement of devices during diagnostic and interventional procedures.
CONTRAINDICATIONS
These guide wires are not intended for Percutaneous Transluminal Coronary Angioplasty
use.
WARNINGS/ADVERSE REACTIONS
•
Inspect wire for damage prior to use, do not use a wire that has been bent, kinked,
or damaged. Use of a damaged wire may result in vessel damage or wire fragment
release into the vessel.
•
Do not reshape the hydrophilic wire by any means. Attempting to reshape the wire
may cause damage to the wire.
•
Do not manipulate or withdraw the wire through a metal entry needle or a metal
dilator, or use this wire with devices which contain metal parts such as atherectomy
catheters or laser catheters or metal torque devices. This may result in destruction
and /or separation of the outer polyurethane coating requiring retrieval. A plastic
entry needle is recommended when using this wire for initial placement, or a
catheter, introducer sheath or vessel dilator should replace the needle as soon as the
guide wire has been inserted into the vessel.
•
Never advance the guide wire against resistance without first determining the reason
for the resistance under fluoroscopy. If resistance occurs and the cause of resistance
cannot be determined, remove the guide wire and device as a unit. Excessive force
against resistance may result in damage to the wire and/ or to the vessel.
•
When manipulating, advancing, exchanging, or withdrawing a catheter over the
wire, secure and maintain the guide wire in place under fluoroscopy to avoid
unexpected guide wire advancement; otherwise damage to the vessel wall by the
wire's tip may occur.
•
The hydrophilic guide wire should be used only by a physician, who is well trained in
manipulation and observation of guide wires under fluoroscopy.
WARNINGS/ADVERSE REACTIONS
•
Thrombus
•
Emboli
•
Arterial or venous vessel wall damage
•
Plaque dislodgment
•
Hematoma at the puncture site
•
Infection
•
Vessel perforation
•
Vessel spasm
•
Hemorrhage
•
Vascular thrombosis
•
Other potential access site complications leading to bleeding, dissection, or
perforation that may require intervention.
PRECAUTIONS
•
When using a drug or a device concurrently with the wire, the operator should have
a full understanding of the properties/characteristics of the drug or device so as to
avoid damage to the hydrophilic guide wire.
•
Use care when manipulating this guide wire through a tightened Hemostasis valve.
CAUTIONS
•
At least 5 cm of the wire should protrude from the device hub at all times to prevent
the wire from sliding entirely into the device due to the low sliding friction of this
wire.
English
•
Merit Medical hydrophilic guide wires are packaged in a plastic hoop fitted with a
luer hub. This packaging is provided to facilitate compliance with the manufacturer
recommended guidelines that the wire must be flushed with saline or heparinized
saline prior to use (See instructions for use).
•
Contents of unopened, undamaged package are sterile and non-pyrogenic.
PREPARATION FOR USE
1.
The surface of the hydrophilic guide wire is not lubricious unless it is wet. Before
attempting to remove the guide wire from its' dispenser, inject sterile heparinized
saline solution into the luer lock hub end of the dispenser to fill the dispenser coil.
This will completely cover the guide wire surface, activate the hydrophilic coating,
and make the guide wire very lubricious.
WARNING: Failure to hydrate the dispenser hoop prior to guide wire removal may
result in guide wire damage and or difficult removal from the dispenser.
2.
After hydrating the guide wire, gently grasp the J-straightener device and pull
from the dispenser, once the straightener is separated from the dispenser,
continue to remove the wire from the hoop.
3.
If guide wire is not properly hydrated, it will be difficult to remove from the
dispenser. Inject additional heparinized saline solution into dispenser and repeat
step # 2.
PRIOR TO USE
CAUTION
CAUTION: The safety and effectiveness of the Merit Hydrophilic Guide Wire has
1.
not been established in the Coronary or Neuro vasculature.
2.
WARNING: Preclinical testing with this device shows 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.
INSTRUCTIONS FOR USE
1.
Fill concurrent device with heparinized saline solution before and during use to
ensure smooth movement of the hydrophilic guide wire within the device.
2.
Use of sterilized gauze moistened with heparinized saline solution and/or a non
metal torque device will facilitate handling of the wire.
3.
Insert the guide wire into the device and advance to the desired location.
WARNING: If movement of the wire within the device becomes diminished,
remove guide wire and reactivate the hydrophilic coating by wetting its entire
surface with a heparinized saline solution.
4.
Wipe the guide wire with a 4x4 gauze moistened with heparinized saline solution
to remove excess blood from the guide wire surface.
WARNING: Do not use dry gauze as this may damage the guide wire surface
resulting in increased resistance when the wire is reinserted into the device.
5.
Re-hydrate the guide wire prior to reinsertion into any device or placement into a
patient. If additional resistance is felt after re-hydration, replace guide wire.
6.
Use of alcohol, antiseptic solutions, or other solvents must be avoided.
WARNING: These solutions may adversely affect the surface of the hydrophilic
guide wire.
7.
After cleaning the wire, place into the saline filled hoop, proximal end first. The
wire may also be placed in a guide wire basin and completely covered with
heparinized saline solution.
WARNING: Hydrophilic guide wires must be kept hydrated through out the entire
8.
procedure. Re-hydrate as necessary when the surface starts to dry out.
of a physician.
REUSE PRECAUTION STATEMENT
For single p atient use only. D o not reuse, repro cess or res terilize. R euse,
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.
Caution: Federal (USA) law restricts this device to sale by or on the order
Do not withdraw through metal devices.
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