Merit Medical Tenor Steerable Guidewire IFU - Manual (Page 4)

DESCRIPTION
This Tenor Steerable Guidewire (0.014” or 0.018”)
is a stainless steel guidewire with a polymer distal
tip and a 3 cm radiopaque distal tip that is
shapeable for 1 cm. The distal 50 cm is coated
with a hydrophilic coating. The guidewire length
is depicted on the product label.
INDICATIONS FOR USE
The Tenor Steerable Guidewire is intended to
facilitate the placement of catheters within the periph-
eral vasculature for various diagnostic and interven-
tional procedures.
WARNING
•
Contents supplied sterile.
• Do not use if pouch is opened or damaged. Verify
that the package integrity has been maintained
to ensure the sterility of the device.
• Do not use in case of any surface irregularities,
bends, or kinks. Any damage of the guidewire
may change its characteristics likely to affect its
performance
• Use the device prior to the “Use Before” date
noted on the package.
• For single patient use only.
Do not reuse, reprocess, or resterilize.
Reusing , reprocessing or resterilizing 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. Reusing,
reprocessing or resterilizing 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. Contami-
nation of the device may lead to injury, illness or
death of the patient.
• Discard the product after use.
• This device should be used only by
physicians thoroughly trained in percutaneous,
intravascular techniques and procedures in
relevant areas of the anatomy.
• Do not attempt to move the guidewire
without observing the guidewire tip. Always
maintain visualization of the guidewire under
fluoroscopy.
• Do not push, pull, or rotate the wire against resis-
tance. If resistance is met, discontinue movement
of the guidewire, determine the
reason for resistance, and take appropriate action
before continuing. Movement of the catheter or
guidewire against resistance may result in separa-
tion of the catheter or
guidewire tip, damage to the catheter, or
vessel perforation.
• The hydrophilic coating has an extremely
lubricious surface only when properly
hydrated.
PRECAUTIONS
•
Do not expose guidewires to extreme
temperatures or solvents.
• Prior to use, carefully examine the guidewire and
packaging to verify proper function and integrity.
• Extreme care should be taken when shaping the
guidewire distal tip. Over-manipulation of the
guidewire distal tip may cause damage. Damaged
guidewires should not be used.
COMPLICATIONS
Procedures requiring percutaneous catheter introduc-
tion should not be attempted by physicians unfamiliar
with the possible complications listed below. Possible
complications may include, but are not limited to, the
following:
• Hemorrhage
• Infection
• Ischemia
•
Perforation of vessel or arterial wall
• Puncture site hematoma
• Thrombus formation
• Vasospasm
•
Vessel wall dissection
PREPARATION FOR USE
•
Open carefully the pouch and remove the hoop
from the pouch
• Flush the hoop with heparinized saline prior to
guidewire removal.
• Remove the guidewire from the hoop.
• If the guidewire is to remain unused at
any time during the procedure, be sure to rehy-
drate with heparinized saline prior
to reinsertion.
INSTRUCTIONS FOR USE
•
The distal tip of the guidewire can be carefully
shaped to the desired tip configuration, using
standard practices.
• Insert the steerable guidewire, flexible end first,
into the catheter lumen using a guidewire inser-
tion tool. Test the guidewire for free movement
within the catheter. Then, advance the catheter
into the guide catheter. During this step, exercise
caution not to allow the guidewire to protrude
beyond the catheter tip, this may damage it.
• To aid in rotating or steering the guidewire,
secure the supplied torque device to the
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