1
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
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035 PTA Dilatation Catheter is a semi-compliant balloon catheter
consisting of an over the wire (OTW) catheter with an angioplasty balloon fixed at the
distal tip. Two radiopaque markers delineate the working length of the balloon and aid in
balloon placement. The catheter also includes a radiopaque, atraumatic tip.
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Marker Bands are designated on the catheter shaft by 1cm increment bands. Each 10cm
increment is labeled with the distance from the distal balloon tip. Thicker bands denote
the midway point (5cm) between the labeled distances.
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Marker Bands are
designed to be used as a location reference tool.
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Marker Bands are also
designed to be used as a guide to assist with geographic alignment when used with an
adjunctive therapy that utilizes the same
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Marker Bands. The
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035 PTA Dilatation Catheter is compatible with .035" guidewires. The proximal portion of
the catheter includes a female luer lock hub connected to the catheter with a guidewire
lumen and an inflation lumen. Packaged with every product is a protective sheath that is
positioned over the balloon and should be removed prior to use. A stylet is placed into
the tip of the catheter to aid in rewrap/refolding of the balloon. A re-wrapping tool is also
provided on the catheter shaft. These products are not made with natural rubber latex.
Figure 1
Figure 1a
(Enhanced Graphic of Catheter Shaft from Figure 1)
5cm
10cm
1cm
1cm
NOTE:
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Marker Bands are non-radiopaque and designed to be utilized
outside the introducer sheath/guide catheter.
Indications For Use
The
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035 PTA Dilatation Catheter is intended to dilate stenoses in the
peripheral arteries, to treat obstructive lesions of native or synthetic AV fistulae and/
or re-expand endoluminal stent graft elements in the iliac arteries. 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. Do not reuse, reprocess or
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 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, the location of the
balloon should be confirmed 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 or
catheter breakage, catheter kink, 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.
2.
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035 PTA Dilatation Catheter shall only be used by physicians
experienced in the performance of percutaneous transluminal angioplasty.
3. The minimal acceptable introducer sheath French size is printed on the package
label. Do not attempt to pass the PTA catheter through a smaller size introducer
sheath than indicated on the label.
4. Use the recommended balloon inflation medium (25% contrast medium/75% sterile
saline solution). It has been shown that a 25%/75% contrast/saline ratio has yielded
faster balloon inflation/deflation times. Never use air or other gaseous medium to
inflate the balloon.
5. If resistance is felt during post procedure withdrawal of the catheter through the
introducer sheath/guide catheter, determine if contrast is trapped in the balloon with
fluoroscopy. If contrast is present, push the balloon out of the introducer sheath/guide
catheter and then completely evacuate the contrast before proceeding to withdraw
the balloon.
6. If resistance is still felt during post procedure withdrawal of the catheter, it is
recommended to remove the balloon catheter and introducer sheath/guide catheter
as a single unit.
7. Do not continue to use the balloon catheter if the catheter shaft has been bent or
kinked.
8. Prior to re-insertion through the introducer sheath/guide catheter, the balloon should
be wiped clean with gauze and rinsed with sterile normal saline.
9. Balloon re-wrapping should only occur while the balloon catheter is supported with a
guidewire or stylet.
10.
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Marker Bands are designed to be used only as an additional reference
tool to accompany the interventionalist standard operation procedure.
Potential Adverse Reactions
The complications that 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 For Use
• Contrast medium
• Sterile saline solution
• Luer lock syringe/inflation device with manometer (10 ml or larger)
• Appropriate introducer sheath/guide catheter and dilator set
