AngioSculpt PTA Manual Del Usuario

English
INSTRUCTIONS FOR USE
AngioSculpt® Percutaneous Transluminal Angioplasty (PTA)
Scoring Balloon Catheter
CAUTION: Federal (USA) law restricts this device to sale by
or on the order of a physician.
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO
USE: FAILURE TO OBSERVE ALL WARNINGS AND
PRECAUTIONS MAY RESULT IN COMPLICATIONS.
NOTE: These instructions apply to all balloon diameters
and lengths.
STERILE: Sterilized with ethylene oxide gas. Non-
pyrogenic. Do not use if the package is open
or damaged.
CONTENTS: One (1) AngioSculpt PTA Scoring
Balloon Catheter
STORAGE: Store in a dry, dark, cool place.
I. DEVICE NAME
The device name is AngioSculpt PTA Scoring Balloon
Catheter; the generic device name is PTA Balloon
Dilatation Catheter.
II. DEVICE DESCRIPTION
The AngioSculpt Scoring Balloon Catheter is a standard
balloon dilatation catheter with a scoring balloon near the
distal tip. One lumen is used for inflation of the balloon
with contrast medium; the other lumen permits the use of a
guide wire to facilitate advancement of the catheter to and
through the stenosis to be dilated. The product is offered
on an over-the-wire (OTW) delivery platform.
The distal end of the catheter has a conventional nylon-
blend balloon and a nitinol scoring element with three or
more (depending on balloon size) spiral struts that wrap
around the balloon. The struts create focal concentrations
of dilating force, which minimize balloon slippage and
assists in the luminal expansion of stenotic arteries.
The balloon has radiopaque markers to aid in positioning
the balloon in the stenosis, and is designed to provide an
expandable segment of known diameter and length at a
specific pressure.
Product specification information including balloon
diameters, balloon lengths, guidewire compatibility, sheath
compatibility and catheter lengths can be found in Table 1.
III. INDICATIONS
The AngioSculpt PTA Scoring Balloon Catheter is intended
for dilatation of lesions in the iliac, femoral, ilio-femoral,
popliteal, infra popliteal, and renal arteries, and for the
treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. Not for use in the coronary or
neuro-vasculature.
PN-3262-0001, Rev D 03/20
Table 1: Product Specifications
Balloon Balloon Guide Wire
Diameter Length Compati­
(mm) (mm) bility
2.0 10 0.014"
2.0 20 0.014"
2.0 40 0.014"
2.0 40 0.014"
2.0 100 0.014"
2.0 100 0.014"
2.5 20 0.014"
2.5 40 0.014"
2.5 40 0.014"
2.5 100 0.014"
2.5 100 0.014"
3.0 20 0.014"
3.0 40 0.014"
3.0 40 0.014"
3.0 100 0.014"
3.0 100 0.014"
3.5 20 0.014"
3.5 40 0.014"
3.5 40 0.014"
3.5 100 0.014"
3.5 100 0.014"
4.0 20 0.018"
4.0 40 0.018"
4.0 40 0.018"
4.0 100 0.014"
4.0 100 0.014"
5.0 20 0.018"
5.0 40 0.018"
5.0 40 0.018"
5.0 100 0.014"
5.0 100 0.014"
6.0 20 0.018"
6.0 20 0.018"
6.0 20 0.018"
6.0 40 0.018"
6.0 40 0.018"
6.0 40 0.018"
6.0 100 0.014"
6.0 100 0.014"
IV. CONTRAINDICATIONS
None known for Percutaneous Transluminal Angioplasty
(PTA) procedures.
V. WARNINGS
This device is intended for single (one) patient use only.
Do not resterilize and/or reuse, as this can potentially result
Sheath Catheter
in compromised device performance and increased risk of
Compati­ Length
inappropriate resterilization and cross contamination.
bility (F) (cm)
The inflated diameter of the balloon should approximate
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the diameter of the vessel just proximal and distal to the
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stenosis, in order to reduce potential vessel damage.
5F 137
When the catheter is exposed to the vascular system,
it should be manipulated while under high quality
5F 155
fluoroscopic observation.
6F 137
Do not advance or retract the catheter unless the balloon
6F 155
is fully deflated under vacuum. If resistance is met during
manipulation, determine the cause of the resistance
5F 137
before proceeding.
5F 137
Balloon pressure should not exceed the rated burst pressure
5F 155
(RBP). Refer to product label for device specific information.
The RBP is based on results of in-vitro testing. At least 99.9%
6F 137
of the balloons (with a 95% confidence level) will not burst
6F 155
at or below their RBP. Use of a pressure monitoring device is
5F 137 recommended to prevent over-pressurization.
5F 137 Use only the recommended balloon inflation medium.
Never use air or any gaseous medium to inflate the balloon.
5F 155
Proceed cautiously when using the AngioSculpt catheter
6F 137
in a freshly deployed bare metal or drug eluting stent. The
6F 155
AngioSculpt catheter has not been tested for post-dilation
of stents or in lesions distal to freshly deployed stents in
5F 137
clinical studies. Bench testing has shown no additional risk
5F 137
when inserting or withdrawing the AngioSculpt catheter
through stents (no interference with stent struts, no
5F 155
retention of or damage to the AngioSculpt catheter).
6F 137
Use the catheter prior to the "Use Before" (expiration) date
6F 155
specified on the package.
6F 137
VI. PRECAUTIONS
A thorough understanding of the principles, clinical
6F 90
applications and risks associated with PTA is necessary
6F 137
before using this product.
6F 90
Any use for procedures other than those indicated in these
6F 137 instructions is not recommended.
The device is not recommended for use in lesions
6F 137
which may require inflation pressures higher than those
6F 90
recommended for this catheter.
6F 137
Do not use if package is opened or damaged.
6F 90
Prior to angioplasty, the catheter should be examined to
verify functionality, device integrity and to ensure that its
6F 137
size and length are suitable for the specific procedure for
6F 50
which it is to be used.
6F 90
During and after the procedure, appropriate anti-
6F 137
coagulants, anti-platelet agents and vasodilators should
be administered to the patient according to institutional
6F 50
practice for peripheral angioplasty of similar arteries.
6F 90
Pass the AngioSculpt catheter through the recommended
6F 137
introducer sheath size or minimum size guiding catheter
indicated on the product label.
6F 90
VII. ADVERSE EFFECTS
6F 137
Possible adverse effects include, but are not limited to,
those listed in Table 2 below:
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