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FLEXOR® INTRODUCER / FLEXOR® GUIDING
SHEATH
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
Flexor Introducers and Guiding Sheaths are designed to perform as a guiding
sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths
incorporate a Flexor shaft with a hemostasis valve and are provided with
one or more dilators. These devices are available in various sizes, lengths and
configurations. Configurations include differences in shaft construction, such
as varying shaft stiffness and distal tip material and shape, dilator material,
hydrophilic coating and/or distal radiopaque markers. Refer to the product
label for product specifications (i.e., sheath inner diameter, dilator inner
diameter, distal curve configuration, hemostasis valve design).
INTENDED USE
Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic
or diagnostic devices into the vasculature, excluding coronary and neuro
vasculature.
CONTRAINDICATIONS
None known
WARNINGS
• If resistance is encountered during advancement of Flexor sheath, assess
cause of resistance and consider dilation of any restriction identified or
consider alternate treatment strategy. If Flexor sheath is advanced through
resistance, force to remove the sheath will be higher, increasing the risk of
sheath material or hub separation upon withdrawal.
• Reinsertion of dilator prior to removal of Flexor sheath increases
the strength of the sheath and lessens the risk of device separation.
If resistance is anticipated or encountered during withdrawal of
Flexor sheath, consider carefully reinserting the dilator prior to
continuing removal.
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.
• In order to ensure device compatibility, choose a sheath size large enough
to accommodate the maximum outer diameter of any devices that will be
placed through the sheath.
• All interventional or diagnostic instruments used with this product should
move freely through the valve and sheath to avoid damage.
• Do not attempt to heat or reshape the device.
• When inserting, manipulating or withdrawing a device through the sheath,
always maintain sheath position.
• When puncturing, suturing or incising the tissue near the sheath, use
caution to avoid damaging the sheath.
• The potential effects of phthalates on children or pregnant/nursing
women 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. Ensure that the inner diameter (ID) of the sheath is appropriate for the
maximum diameter of the instruments to be introduced.
2. Using the side-arm of the valve, flush the sheath by filling the sheath
assembly completely with heparinized saline.
3. Flush the dilator with heparinized saline.
4. Insert the dilator completely into the sheath. If the sheath has a Tuohy-
Borst valve, tighten the valve around the dilator.
5. If the device has hydrophilic coating, activate the coating by wetting
the outer surface of the device with heparinized saline. NOTE: For best
results, maintain wetted condition of device during placement.
3
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