I N S T R U C T I O N S F O R U S E
DESCRIPTION: The Mistique Infusion Catheter is a
5 French (1.7mm) catheter with multiple side holes.
INDICATIONS FOR USE: The Mistique Infusion Catheter is
intended to administer infusions of various therapeutic solutions
into the peripheral vasculature of a patient.
CONTRAINDICATIONS:
The Mistique Infusion Catheter is contraindicated for use in the
coronary vasculature.
The Mistique Infusion Catheter is contraindicated for use during
magnetic resonance imaging.
CAUTIONS:
Do not use the Mistique Infusion Catheter with a power injector.
The Mistique Infusion Catheter should only be used by physicians
who have a thorough understanding of infusion therapies and
the associated complications of those infusion therapies.
Refer to the product insert of the therapeutic solution for
indications, contraindications, cautions, and warnings.
When introducing the Mistique Infusion Catheter through a
synthetic graft, an introducer sheath should be used. Damage to
the infusion catheter may occur if no introducer sheath is used.
WARNINGS: Correct placement of the guiding wire and catheter
should be verified by fluoroscopy. Failure to use fluoroscopy could
result in incorrect placement resulting in patient injury or death.
A guide wire should never be advanced or withdrawn against
resistance. If a guide wire is advanced where there is resistance,
it could cause vessel trauma and/or wire damage. The cause
of the resistance should be determined utilizing fluoroscopy.
All components must be adequately flushed with heparinized
saline to displace air prior to insertion into the body.
Complications may occur if air has not been displaced.
Ensure that all connections are secure before use. Do not over
tighten as excessive force may damage the product.
This device is intended for single use only.
Federal (USA) law restricts this device to sale by or on the order
of a physician.
Store in a cool dry place.
Patent # 5,957,901 Other U.S. and foreign patents pending.
I N F U S I O N C A T H E T E R
DESCRIPTION OF DEVICE:
The Mistique Infusion Catheter is a 5 French (1.7mm) catheter with
multiple side holes around the circumference of the catheter. The
infusion portion of the catheter is identified with radiopaque marker
bands to facilitate placement under fluoroscopy. The Mistique is
available in a 0.035" (0.89mm) end hole design or a
0.038" (0.97mm) end hole design.
INSTRUCTIONS FOR USE:
1. Flush the Mistique Infusion Catheter with sterile, heparinized
saline to displace any air prior to placement.
2. The Mistique Infusion Catheter will pass through a standard
5 French sheath introducer.
3. Place the Mistique Infusion Catheter into position under
fluoroscopic guidance over the appropriate guide wire following
standard hospital protocol.
4. Leave the guide wire in place to facilitate infusion of therapeutic
solution through the catheter side holes.
5. The two radiopaque marker bands on the Mistique Infusion
Catheter indicate the segment where side hole infusion occurs.
6. The Mistique Infusion Catheter may be used for pulse or slow,
continuous infusion of the therapeutic agent, as ordered by the
physician. The rate and duration of infusion should be
determined by the physician.
7. The Mistique Infusion Catheter is for one
time patient use only. Do not reuse.
Merit Medical Systems, Inc. South Jordan, Utah 84095 • www.merit.com
U.S.A. 1-801-253-1600 U.S.A. Customer Service 1-800-356-3748
Merit Medical Ireland Ltd, Parkmore Business Park West, Galway, Ireland
400411002/A ID 120502
(2 pages)
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