Bard Atlas GOLD Instrucciones De Uso

PTA Dilatation Catheter
ENGLISH
INSTRUCTIONS FOR USE
CAUTION: Federal (U.S.A.) law restricts this device to
sale by or on the order of a physician.
Device Description
The A PTA Dilatation Catheter is a high
®
TLAS GOLD
performance balloon catheter consisting of an over-the-wire
catheter with a balloon fixed at the distal tip. The proprietary
non-compliant, low profile balloon is designed to provide
consistent balloon diameters and lengths even at high
pressures. Two radiopaque markers delineate the working
length of the balloon and aid in balloon placement. The
coaxial catheter includes a tapered atraumatic tip to facilitate
advancement of the catheter to and through the stenosis.
The proximal portion of the catheter includes a female luer
lock hub connected to the inflation lumen, and a female
luer-lock hub connected to the guidewire lumen. The over-
the-wire catheter is compatible with .035" guidewire and is
available in 80cm and 120cm working lengths.
Packaged with every product is a profile reducing sheath
that is positioned over the balloon for protection before use.
A re-wrapping tool is also provided on the catheter shaft to
aid in re-wrap/refolding of the balloon.
This product is not manufactured with any natural rubber
latex.
Indications for Use
A PTA Dilatation Catheter is indicated for use in
®
TLAS GOLD
Percutaneous Transluminal Angioplasty of the iliac arteries
and for the treatment of obstructive lesions of native or
synthetic arteriovenous dialysis fistulae. This device is also
indicated for post-dilatation of stents and stent grafts in
the peripheral vasculature. This catheter is not for use in
coronary arteries.
Contraindications
None known.
Warnings
1. Contents supplied STERILE using ethylene oxide
(EO). Non-Pyrogenic. Do not use if sterile barrier is
opened or damaged. Single patient use only. Do not
reuse, reprocess, or re-sterilize.
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 potential adverse effects on
components that are influenced by thermal and/or
mechanical changes.
4. To reduce the potential for vessel damage, the
inflated diameter and length of the balloon should
approximate the diameter and length of the vessel
just proximal and distal to the stenosis.
5. To reduce the potential for stent or stent graft
damage and/or vessel damage from the stent or
stent graft, the diameter of the balloon should
be no greater than the diameter of the stent or
stent graft. Refer to the stent or stent graft IFU
for safety information including the WARNINGS,
PRECAUTIONS, and potential ADVERSE EFFECTS
regarding the use of balloon post-dilatation.
6. When the catheter is exposed to the vascular
system, it should be manipulated while under high-
quality fluoroscopic observation. Do not advance
or retract the catheter unless the balloon is fully
deflated. If resistance is met during manipulation,
determine the cause of the resistance before
proceeding. Applying excessive force to the
catheter can result in tip breakage or balloon
separation.
7. Do not exceed the RBP recommended for this
device. Balloon rupture may occur if the RBP rating
is exceeded. To prevent over pressurization, use of
a pressure monitoring device is recommended.
8. After use, this product may be a potential
biohazard. Handle and dispose of in accordance
with acceptable medical practices and applicable
local, state, and federal laws and regulations.
Precautions
1. Carefully inspect the catheter prior to use to verify
that catheter has not been damaged during shipment
and that its size, shape, and condition are suitable for
the procedure for which it is to be used. Do not use if
product damage is evident.
2. The A Catheter shall only be used by
TLAS ® GOLD
physicians trained in the performance of Percutaneous
Transluminal Angioplasty.
3. The minimal acceptable sheath French size is printed
on the package label. Do not attempt to pass the PTA
catheter through a smaller size sheath introducer than
indicated on the label.
4. Do not remove the guidewire in situ to shoot contrast
through the wire lumen or perform a wire exchange.
If the wire is removed while the balloon catheter is
situated in tortuous anatomy, the risk of kinking the
catheter is increased.
5. Use the recommended balloon inflation medium (a
range of 30-50% contrast medium / a range of 50-70%
sterile saline solution). It has been shown that a 30/70%
contrast/saline ratio has yielded faster balloon inflation /
deflation times.
6. Never use air or other gaseous medium to inflate the
balloon.
7. If resistance is felt during post procedure withdrawal of
the catheter through the introducer sheath, determine
if contrast is trapped in the balloon with fluoroscopy. If
contrast is present, push the balloon out of the sheath
and then completely evacuate the contrast before
proceeding to withdraw the balloon.
8. If resistance is still felt during post procedure withdrawal
of the catheter, it is recommended to remove the
balloon catheter and guidewire/introducer sheath as a
single unit.
9. Do not continue to use the balloon catheter if the shaft
has been bent or kinked.
10. Prior to re-insertion through the introducer sheath, the
balloon should be wiped clean with gauze, rinsed with
sterile normal saline, and refolded with the balloon
re-wrap tool. Balloon re-wrapping should only occur
while the balloon catheter is supported with a guidewire.
Potential Adverse Reactions
The complications which may result from a peripheral
balloon dilatation procedure include:
Additional intervention
Allergic reaction to drugs or contrast medium
Aneurysm or pseudoaneurysm
Arrhythmias
mbolization
ematoma
emorrhage, including bleeding at the puncture site
ypotension/hypertension
Inflammation
cclusion
Pain or tenderness
Pneumothorax or hemothorax
epsis/infection
hock
hort term hemodynamic deterioration
troke
Thrombosis
essel dissection, perforation, rupture, or spasm
Directions for Use
Handling & Storage
tore in a cool, dry, dark place. Do not store near radiation
or ultra-violet light sources.
Rotate inventory so that the catheters and other dated
products are used prior to the "Use By" date.
Do not use if packaging is damaged or opened.
Equipment for Use
Contrast medium
terile saline solution
uer lock syringe/inflation device with manometer (10 ml
or larger)
Appropriate introducer sheath and dilator set
.035" guidewire
Dilatation Catheter Preparation
1. Remove Catheter from package.
2. erify the balloon size is suitable for the procedure and
the selected accessories accommodate the catheter as
labeled.
3. Remove the balloon guard by grasping the balloon
catheter just proximal to the balloon and with the other
hand, gently grasp the balloon protector and slide
distally off of the balloon catheter.
4. lide the re-wrap tool to the proximal end of the catheter
shaft.
5. Prior to use, the air in the balloon catheter should
be removed. To facilitate purging, select a syringe or
inflation device with a 10 ml or larger capacity and fill
approximately half of it with the appropriate balloon
inflation medium (30-50% contrast medium / 50-70%
sterile saline solution). Do not use air or any gaseous
medium to inflate the balloon.
6. Connect a stopcock to the balloon inflation female luer
hub on the dilatation catheter.
1
7. Connect the syringe to the stopcock.
8. old the syringe with the nozzle pointing downward,
open the stopcock, and aspirate for approximately
15 seconds. Release the plunger.
9. Repeat step #8 two more times or until bubbles no
longer appear during aspiration (negative pressure).
nce completed, evacuate all air from the barrel of the
syringe/inflation device.
10. Prepare the wire lumen of the catheter by attaching a
syringe to the wire lumen hub and flushing with sterile
saline solution.
Use of the A PTA Dilatation Catheter
®
TLAS GOLD
1. Backload the distal tip of the A
TLAS
the pre-positioned guidewire and advance the tip to the
introduction site.
2. Advance the catheter through the introducer sheath
and over-the-wire to the site of inflation. If the stenosis
cannot be crossed with the desired dilatation catheter,
use a smaller diameter catheter to pre-dilate the lesion
to facilitate passage of a more appropriately sized
dilatation catheter.
3. Position the balloon relative to the lesion to be dilated,
ensure the guidewire is in place and inflate the balloon
to the appropriate pressure.
4. Apply negative pressure to fully evacuate fluid from the
balloon. Confirm that the balloon is fully deflated under
fluoroscopy.
5. While maintaining negative pressure and the position of
the guidewire, withdraw the deflated dilatation catheter
over-the-wire through the introducer sheath. Use of a
gentle clockwise motion may be used to help facilitate
catheter removal through the introducer sheath.
Balloon Reinsertion
Precaution: Do not continue to use the balloon catheter if
the shaft has been bent or kinked.
Precaution: Prior to re-insertion through the introducer
sheath, the balloon should be wiped clean with gauze,
rinsed with sterile normal saline, and refolded with the
balloon re-wrap tool. Balloon re-wrapping should only occur
while the balloon catheter is supported with a guidewire.
1. oad the balloon catheter onto a guidewire.
2. Advance the balloon re-wrap tool over the catheter to
the proximal end of the balloon.
3. Grasp the catheter shaft just proximal to the balloon
with one hand, and with the other hand gently slide the
rewrap tool over the balloon to the catheter tip and then
back over the balloon to the catheter.
4. lide the re-wrap tool to the proximal end of the catheter
shaft.
5. Advance the balloon catheter over the pre-positioned
guidewire to the introduction site and through the
introducer sheath. If resistance is encountered, replace
the previously used balloon catheter with a new balloon.
6. Continue the procedure according to the "Use of the
A PTA Dilatation Catheter" section herein.
®
TLAS GOLD
Warning: After use, this product may be a potential
biohazard. Handle and dispose of in accordance with
acceptable medical practices and applicable local, state
and federal laws and regulations.
Warranty
Bard Peripheral ascular 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 ascular 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.
ome 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 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
ascular to see if additional product information is available.
Catheter over
®
GOLD