Contraindications - COOK Medical CHECK-FLO PERFORMER Mode D'emploi

CHECK-FLO PERFORMER® INTRODUCER
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or a properly licensed practitioner).
DEVICE DESCRIPTION
Performer introducers are designed to perform as a guiding sheath and/
or introducer sheath and come with a Check-Flo® valve. Some Performer
introducers are available with a radiopaque tip incorporated in the sheath
material to identify the location of the sheath's distal tip.
INTENDED USE
Performer introducers and guiding sheaths are intended to introduce
therapeutic or diagnostic devices into the vasculature.

CONTRAINDICATIONS

This device is not intended for coronary and neurovascular use.
WARNINGS
Before withdrawing the sheath through tortuous anatomy, insert the
introducer dilator to avoid possible breakage.
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.
• The maximum diameter of the instrument or catheter to be introduced
should be determined to ensure that it will pass through the introducer.
• All instruments or catheters used with this product should move freely
through the valve and sheath. Damage to the valve/introducer may result
when the fit is tight.
• When inserting, manipulating or withdrawing a device through an
introducer always maintain introducer position.
• Before removing or inserting devices through the introducer, aspirate
through the side-arm of the valve to clear the introducer, then flush with
heparinized saline.
• When inflating a balloon at, or close to, the introducer tip, ensure the
balloon is not inside the distal tip of the introducer.
• When puncturing, suturing or incising the tissue near the introducer, use
caution to avoid damaging the introducer.
• 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
Adverse events that may be associated with the use of an introducer set
include, but are not limited to:
• Bleeding
• Extravasation
• Hematoma
• Vessel laceration
• Vessel perforation
• Local inflammation
• Local pain
• Access site infection
• Distal embolization
INSTRUCTIONS FOR USE
Sheath Introduction
1. Upon removal from package, ensure the inner diameter (ID) of the
introducer is appropriate for the maximum diameter of the instrument or
catheter to be introduced.
2. Using the side-arm of the valve, flush the introducer by filling the
introducer assembly completely with heparinized saline.
3. Flush the dilator with heparinized solution.
4. Insert the dilator completely into the introducer.
5. Using standard Seldinger technique, access the target vessel with the
appropriate needle.
6. Insert an appropriate wire guide into the vessel through the needle, then
remove the needle, leaving the wire guide in place.
7. Insert the dilator/sheath combination over the wire guide.
8. Remove the wire guide and dilator; aspirate and flush the introducer side-
arm.
9. Insert an appropriately sized device as needed.
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ENGLISH