Directions For Use - Bard Impra Instrucciones De Uso

INSTRUCTIONS FOR USE
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of
a physician.
Device Description, Indications, Contraindications, Warnings,
Precautions and Adverse Reactions
Device Description
The Expanded PTFE (ePTFE) Cardiovascular Patch is constructed from
expanded polytetrafluoroethylene. All Cardiovascular Patches are supplied
sterile and non-pyrogenic unless the package is opened or damaged. This is a
single use device.
Indications for Use
The Cardiovascular Patch is indicated for use in repair and closure of the
cardiovascular system.
Contraindications
The Cardiovascular Patch is NOT indicated for:
• Reconstruction of hernias and tissue deficiencies.
• Reconstruction and repair of passive biological membranes such as dura
mater, pericardium, or peritoneum.
Use of this prosthesis in noncardiovascular applications can cause potentially
serious complications, such as suture pull out, failure of closure or repair, or
undesired healing to surrounding tissues.
Warnings
1. Cardiovascular Patches are supplied sterile and non-pyrogenic unless
the package is opened or damaged. Cardiovascular Patches are
sterilized by ethylene oxide. Each patch is intended for single patient
use only. DO NOT RESTERILIZE.
2. This device has been designed for single use only. Reusing this
medical device bears the risk of cross-patient contamination as
medical devices – particularly those with long and small lumina, joints,
and/or crevices between components – are difficult or impossible to
clean once body fluids or tissues with potential pyrogenic or microbial
contamination have had contact with the medical device for an
indeterminable period of time. The residue of biological material can
promote the contamination of the device with pyrogens or
microorganisms which may lead to infectious complications.
3. Do not resterilize. After resterilization, the sterility of the product is not
guaranteed because of an indeterminable degree of potential pyrogenic
or microbial contamination which may lead to infectious complications.
Cleaning, reprocessing and/or resterilization of the present medical
device increases the probability that the device will malfunction due to
and/or mechanical changes.
4. Do not use after expiration date printed on the label.
5. Cardiovascular Patches are not elastic. Care must be taken to cut the
patches sufficiently large enough to eliminate anastomotic stresses.
6. Exposure to solutions (e.g., alcohol, oil, aqueous solutions, etc.) may
result in loss of the patch's hydrophobic properties. Loss of the
hydrophobic barrier may result in patch wall leakage. Preclotting of
this patch is unnecessary.
7. Avoid excessive patch manipulation or pressure after exposure to
blood or body fluids, as loss of the patch's hydrophobic properties
may occur. Loss of the hydrophobic barrier may result in patch
leakage.
8. After use, this product may be a potential biohazard. Handle and
dispose of in accordance with accepted medical practice and
applicable local, state and federal laws and regulations.
Precautions
1. Only physicians qualified in cardiovascular surgery techniques should use
this prosthesis. The healthcare provider is responsible for all appropriate
postoperative care instructions to the patient.
2. When suturing, avoid excessive tension on the suture line, inappropriate
suture spacing and bites, and gaps between the patch and host vessel.
Failure to follow correct suturing techniques may result in suture hole
elongation, suture pull-out, anastomotic bleeding and/or disruption. Refer to
"Suturing" for further instructions.
3. DO NOT use absorbable sutures.
4. DO NOT use less than a 2 mm suture bite in cardiac and great vessel
applications.
5. DO NOT use less than a 1 mm suture bite in peripheral vascular
applications.
6. DO NOT suture two patches together to make a larger patch.
7. DO NOT contaminate or damage the patch.
8. DO NOT patch in areas that may be subjected to repeated punctures.
Adverse Reactions
Possible complications with the use of any cardiovascular patch include, but are
not limited to: infection, thrombus formation, anastomotic blood leakage,
peripatch seroma formation, pseudoaneurysm formation, and hematomas.

DIRECTIONS FOR USE

Equipment Required
Vascular forceps, needle holder, taper point, non-resorbable sutures, and topical
hemostatic agent.
Opening the Package
Hold the outer tray in one hand. Peel back the lid. Remove the inner tray. Peel
back the inner tray lid slowly and carefully remove the patch using sterile
atraumatic instruments or gloves. Protect the patch against damage from sharp
or heavy instruments. The patch is ready to be sized for repair or closure.
Sizing
It is critical that the patch be cut to the proper size for closure or repair. Cutting
the patch too small increases the tension on the suture line which may result in
elongated suture holes, thus causing increased suture line bleeding. Never
suture two patches together to form a larger patch. This is not an accepted
design criteria of the patch and may result in an inadequate repair or closure.
Suturing
Best results are achieved using a tapered, non-cutting needle with a non-
absorbable monofilament suture approximately the same size as the needle.
Follow the curve of the needle to minimize suture hole elongation and bleeding
from suture holes. Application of a topical hemostatic agent may aid in
controlling any bleeding that may occur. The manufacturer's instructions for
these products should be followed.
When placing a suture, avoid excessive tension on the suture line and
incorporate sufficient material in the stitch. Use a minimum 2 mm suture bite for
cardiac and great vessel repairs; a minimum 1 mm suture bite for peripheral
vascular applications.
Warranty
Bard Peripheral Vascular, Inc. warrants to the first purchaser of this product that
this product will be free from defects in materials and workmanship for a period
of one year from the date of first purchase and liability under this limited product
warranty will be limited to repair or replacement of the defective product, in Bard
Peripheral Vascular, Inc.'s sole discretion or refunding your net price paid. Wear
and tear from normal use or defects resulting from misuse of this product are
not covered by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED
PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES,
WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO,
ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. IN NO EVENT WILL BARD PERIPHERAL
VASCULAR BE LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR
USE OF THIS PRODUCT.
Some countries do not allow an exclusion of implied warranties, incidental or
consequential damages. You may be entitled to additional remedies under the
laws of your country.
An issue or revision date and a revision number for these instructions are
included for the user's information on the last page of this booklet. In the event
36 months have elapsed between this date and product use, the user should
contact Bard Peripheral Vascular, Inc. to see if additional product information is
available.
(1)