BD UltraScore Gebrauchsanweisung

Focused Force PTA Balloon
ENGLISH
INSTRUCTIONS FOR USE
CAUTION: Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.
Information in the Instructions for Use should be discussed with the patient, at the discretion
of the physician.
Device Description
The U S Focused Force PTA Balloon consists of a flexible, over-the-wire (OTW)
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catheter shaft with a semi-compliant balloon fixed at the distal end. For all balloon lengths,
radiopaque markers delineate the working length of the balloon and aid in balloon placement.
For balloon lengths of 100 mm and greater, two radiopaque markers are positioned on the
distal portion of the balloon and one radiopaque marker is positioned on the proximal portion
of the balloon to differentiate between the distal and proximal ends of the balloon. The catheter
includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis.
Two scoring wires, oriented 180° apart, provide focused force upon dilatation. The U
Focused Force PTA Balloon is compatible with .014" or .035" guidewires, as denoted by the
product labeling. The distal portion of the .014" guidewire compatible catheters is hydrophilically
coated to facilitate catheter advancement through the vasculature and the vessel stenosis. 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 must be removed prior to use. A stylet is placed into the
tip of the catheter. These products are not made with natural rubber latex.
The G a Marking System is a non-radiopaque ruler on the catheter shaft measured from
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the distal tip. The G a markings are designated on the catheter shaft by 1cm increment
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bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in
10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances.
The G a Marking System is designed to be used as a tool to externally measure the
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intravascular advancement and/or retraction of the catheter. This can provide an intravascular
reference regarding the location of the distal tip of the catheter or an approximate intravascular
length measurement between two points. The G
geographic alignment of an adjunctive therapy that includes the same G
Note: The G a Marking System provides an approximation that may not be an exact
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representation of the actual distance traveled intravascularly and should be confirmed under
fluoroscopy.
1 cm
1 cm 5 cm
NOTE: The G a Marking System includes non-radiopaque white markings and are
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designed to be utilized outside the sheath.
The U S Focused Force PTA Balloon provides a clinical benefit with its ability to dilate
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stenoses of the peripheral vasculature through a wide range of sizes (diameter/length).
Indications for Use
The U S Focused Force PTA Balloon is intended to dilate stenoses in the iliac,
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femoral, ilio-femoral, popliteal, infra-popliteal and renal 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 stents, self-expanding stents, and stent
grafts in the peripheral vasculature.
Contraindications
The U S Focused Force PTA Balloon is contraindicated:
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• Where there is the inability to cross the target lesion with a guidewire
• For use in the coronary or neuro vasculature
Warnings
1. Contents supplied STERILE using ethylene oxide (EO). Non-Pyrogenic. Do not use if
sterile barrier is opened, damaged or contamination is evident. Do not reuse, reprocess
or re-sterilize. Use the catheter prior to the "Use By" date specified on the package label.
2. This device has been designed for single patient use. 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. Additionally,
re-use and/or repackaging may compromise the structural integrity and/or material and
design characteristics of the device, which may lead to device failure, and/or lead to
patient injury.
3. Do not resterilize. After resterilization, the sterility of the product is not guaranteed
because of an indeterminable degree of potential pyrogenic or microbial
Figure 1
a Marking System may also facilitate
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a Marking System.
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10 cm
Figure 2
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 or difficulty in deflating, 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 or difficulty
in deflation may occur if the RBP rating is exceeded. To prevent over pressurization,
use of a pressure monitoring device is recommended.
7. After contact with blood or use, this product is a biohazard. Handle and dispose as
a biohazard in accordance with acceptable medical practices and applicable local,
state and federal laws and regulations.
8. The safety and effectiveness of the device has not been established, or is unknown,
in vascular regions other than those specifically indicated.
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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 U S
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experienced in the performance of percutaneous transluminal angioplasty.
3. It is recommended to consider the use of anti-coagulants, anti-platelet agents, and/
or vasodilators in conformance with the accepted standard of practice or institutional
guidelines surrounding peripheral endovascular procedures.
4. For U S
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wet the U S
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with sterile saline saturated gauze immediately prior to its insertion in the body. Avoid
excessively wiping the coated portions of the device, or wiping with dry gauze, as this may
damage the hydrophilic coating.
5. U S .014" guidewire sizes are coated with a hydrophilic coating at the distal
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segment of the shaft and balloon. Please refer to the Directions for Use section for further
information on how to prepare and use this device to ensure it performs as intended.
Failure to abide by the warnings in this labeling might result in damage to the hydrophilic
coating, which may require intervention or result in serious adverse events.
6. The minimal acceptable 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.
7. Use the recommended balloon inflation medium (25% contrast medium/75% sterile saline
solution). Never use air or other gaseous medium to inflate the balloon.
8. The U S
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involving calcified lesions, stents or synthetic vascular grafts due to the abrasive nature of
these lesions.
9. Fully evacuate the balloon prior to withdrawing the system. Larger sizes of U
Focused Force PTA Balloons may exhibit slower deflation times.
10. If resistance is felt during post procedure withdrawal of the catheter through the introducer
sheath, determine if contrast medium 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.
11. 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, and
replace the previously used balloon catheter with a new balloon. Exercise caution when
removing the device.
12. Do not continue to use the balloon catheter if the shaft has been bent or kinked. Do not
excessively bend, twist, or alter the shape of the device as it may compromise the integrity
of the hydrophilic coating.
13. For U S
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sheath, re-activate the hydrophilic coating, and clean the balloon catheter by wiping the
balloon catheter with sterile saline saturated gauze and rinsing with sterile saline. Using
different media other than the recommended solution could affect the hydrophilic coating
and its performance.
14. G a Marking System is designed to be used as an additional reference tool to
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accompany the interventionalist standard operation procedure. The use of fluoroscopic
imaging is recommended following positioning of the catheter to the target lesion and prior
to balloon deployment.
15. Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because
this may cause unpredictable changes in the coating which could affect the device safety
and performance.
16. Avoid pre-soaking devices for extended periods, as this may impact the coating performance.
Potential Adverse Reactions
The complications that may result from a peripheral balloon dilatation procedure include:
• Additional invasive surgery
• Additional non-invasive surgery
• Air embolism
• Aneurysm, pseudoaneurysm
• Arrhythmias
• Excessive or uncontrollable amount of bleeding due to vessel tissue injury or trauma
• Foreign body embolism
• Hematoma
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Focused Force PTA Balloon should only be used by physicians
.014" guidewire sizes only, in order to activate the hydrophilic coating,
balloon and catheter with sterile saline or wipe the balloon catheter
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Focused Force PTA Balloon should be used with caution for procedures
.014" guidewire sizes only, prior to re-insertion through the introducer
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