Bard Peripheral Vascular DORADO 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
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The D
ORADO PTA Balloon Dilatation Catheter is a high
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
catheter includes an atraumatic tip to facilitate advancement
of the catheter to and through the stenosis. The novel catheter
consists of a distal triple lumen and a proximal coaxial lumen
and is designed to optimize the balance between pushabilty
and trackability. The over the wire catheter is compatible with
0.035" guidewire and is available in 40, 80, 120, and 135 cm
working lengths. 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.
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. A stylet
is placed into the tip of the catheter to aid in rewrap/refolding
of the balloon.
These products are not made with natural rubber latex.
Indications for Use
®
D
ORADO Balloon Dilatation Catheters are recommended for
Percutaneous Transluminal Angioplasty (PTA) of the renal,
iliac, femoral, popliteal, tibial, peroneal, and subclavian
arteries and for the treatment of obstructive lesions of native
or synthetic arteriovenous dialysis fistulae. This device is
also recommended for post-dilatation of balloon expandable
and self expanding stents 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. 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.
6. 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.
7. 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.
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2. The D
ORADO catheter shall only be used by 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. Never
use air or other gaseous medium to inflate the balloon.
6. 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.
7. 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.
8. Do not continue to use the balloon catheter if the shaft has
been bent or kinked.
9. 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 or stylet.
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
• Embolization
• Hematoma
• Hemorrhage, including bleeding at the puncture site
• Hypotension/hypertension
• Inflammation
• Occlusion
• Pain or tenderness
• Pneumothorax or hemothorax
• Sepsis/infection
• Shock
• Short term hemodynamic deterioration
• Stroke
• Thrombosis
• Vessel dissection, perforation, rupture, or spasm
Directions for Use
Handling & Storage
Store 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 Required
• Contrast medium
• Sterile saline solution
• Luer lock syringe/inflation device with manometer (10 ml or
larger)
• Appropriate introducer sheath and dilator set
• 0.035" guidewire
Dilatation Catheter Preparation
1. Remove Catheter from package. Verify the balloon size is
suitable for the procedure and the selected accessories
accommodate the catheter as labeled.
2. Remove the balloon guard and stylet 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.
3. Slide the re-wrap tool to the proximal end of the catheter
shaft.
4. 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.
5. Connect a stopcock to the balloon inflation female luer hub
on the dilatation catheter.
6. Connect the syringe to the stopcock.
1
7. Hold the syringe with the nozzle pointing downward, open
the stopcock and aspirate for approximately 15 seconds.
Release the plunger.
8. Repeat step #6 two more times or until bubbles no longer
appear during aspiration (negative pressure). Once
completed, evacuate all air from the barrel of the syringe/
inflation device.
9. Prepare the wire lumen of the catheter by attaching a
syringe to the wire lumen hub and flushing with sterile
saline solution.
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Use of the D
ORADO PTA Dilatation Catheter
1. Backload the distal tip of the D
ORADO
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 and that no contrast is left in the balloon.
5. While maintaining negative pressure and the position of
the guidewire, grasp the balloon catheter just outside the
sheath and 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 or stylet.
1. Load 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. Slide 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
®
D
ORADO Catheter" section herein.
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 Vascular 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'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 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 to see if additional product
information is available.
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balloon catheter over