Contraindications - COOK Medical Micropuncture Mode D'emploi

MICROPUNCTURE® PEDAL INTRODUCER
ACCESS SET
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Micropuncture® Pedal Introducer Access Set contains a 21 gage
introducer needle, a .018 inch wire guide, an introducer catheter, and a
hemostasis valve.
INTENDED USE
This device is intended to introduce up to an 0.038" wire guide into the
peripheral vasculature. It is also used to introduce diagnostic and/or
interventional devices able to pass through the ID of the introducer.

CONTRAINDICATIONS

None known
WARNINGS
None known
PRECAUTIONS
• This product is intended for use by physicians trained and experienced
in diagnostic and interventional techniques. Standard techniques for
placement of vascular access sheaths should be employed.
• When inflating a balloon at, or close to, the introducer tip, ensure the
balloon is not inside the distal tip of the introducer.
• When inserting, manipulating or withdrawing a device through an
introducer, always maintain introducer position.
• Do not attempt to insert or withdraw the wire guide and/or introducer if
resistance is felt.
• Withdrawal or manipulation of the distal spring coil portion of the mandril
wire guide through a needle tip may result in breakage.
• The potential effects of phthalates on pregnant/nursing women or
children have not been fully characterized and there may be concern for
reproductive and developmental effects.
POTENTIAL ADVERSE EVENTS
Potential adverse events that may occur include, but are not limited to, the
following:
• Bleeding
• Edema
• Extravasation
• Hematoma
• Inflammation, necrosis, or scarring
• Laceration of a vessel or viscus
• Pain in region
• Vessel perforation
• Infection at access site
• Wire or catheter embolism
INSTRUCTIONS FOR USE
1. Insert the needle into the vessel.
WARNING: Place a finger over the hub of the needle to minimize
blood loss and the risk of air aspiration.
2. Advance the .018 inch wire guide through the introducer needle.
CAUTION: Do not withdraw the wire guide through the introducer
needle; breakage may result. If the wire guide tip must be withdrawn
while the needle is inserted, remove both the needle and the wire as
a unit.
3. Withdraw the introducer needle, leaving the wire guide in place.
4. Advance the pedal introducer/dilator pair over the wire guide.
5. Remove the dilator and the wire guide, leaving the pedal introducer
in place. WARNING: Place a finger over the orifice of the pedal
introducer to minimize blood loss and the risk of air aspiration.
6. Attach the hemostatic valve to the pedal introducer.
7. Proceed with the planned intervention.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for
one-time use. Sterile if package is unopened or undamaged. Do not use the
product if there is doubt as to whether the product is sterile. Store in a dark,
dry, and cool place. Avoid extended exposure to light. Upon removal from
package, inspect the product to ensure no damage has occurred.
REFERENCES
These instructions for use are based on experience from physicians and
(or) published literature. Refer to your local Cook sales representative for
information on available literature.
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