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STERILE. Sterilized with ethylene oxide gas. Nonpyrogenic.
Radiopaque. For single use only. Do not resterilize.
Caution: Federal (USA) law restricts this device to sale by or on the
order of a physician.
I. Device name
®
The device brand name is Cordis POWERFLEX
Percutaneous Transluminal Angioplasty (PTA) Catheter; the generic
device name is PTA Balloon Dilatation Catheter.
II. Description
®
The Cordis POWERFLEX
PRO Percutaneous Transluminal
Angioplasty (PTA) Catheter is a catheter with a distal inflatable
balloon. Two radiopaque marker bands indicate the dilating
section of the balloon and aid in balloon placement. The catheter
tip is tapered to ease entry into peripheral arteries and to facilitate
the crossing of tight stenoses.
The working pressure range for the balloon is between the
nominal pressure and the rated burst pressure. All balloons distend
to sizes above the nominal size at pressures greater than the
nominal pressure. Consult the compliance chart on the tray label
for typical diameters of the balloons at given pressures.
The balloon lumen, marked "BALLOON" is used to inflate and
deflate the balloon. The nominal balloon size is printed on the hub.
The injectate lumen, marked "THRU" is used to track the catheter
over a prepositioned guidewire or to inject contrast medium and/
or saline (150 psi maximum).
The radiopaque marker bands indicate the stated nominal length
of the balloon.
III. Indications
®
The POWERFLEX
PRO PTA catheter is intended to dilate
stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal
and renal arteries and for the treatment of obstructive lesions of
native or synthetic arteriovenous dialysis fistulae. The device is
also indicated for post-dilation of balloon-expandable and self-
expanding stents in the peripheral vasculature.
IV. Contraindications
None known for PTA procedure. The POWERFLEX
catheter is contraindicated for use in coronary arteries.
V. Warnings
•
This device is intended for one time use only.
•
DO NOT resterilize and/or reuse it, as this can potentially result
in compromised device performance and increased risk of
inappropriate resterilization and cross contamination.
•
To reduce the potential for vessel damage, the inflated
diameter of the balloon should approximate the diameter of
the vessel just proximal and distal to the stenosis.
•
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 under vacuum.
•
If resistance is met during manipulation, determine the cause
of the resistance before proceeding.
•
Balloon pressure should not exceed the rated burst pressure.
The rated burst pressure is based on the results of in vitro
testing. At least 99.9% of the balloons (with a 95% confidence),
will not burst at or below their rated burst pressure. Use of a
pressure monitoring device is recommended to prevent over
pressurization.
•
Use only the recommended balloon inflation medium. Never
use air or any gaseous medium to inflate the balloon.
•
Use the catheter prior to the "Use By" date specified on the
package.
VI. Precautions
•
Prior to angioplasty, the catheter should be examined to verify
functionality and ensure that its size and shape are suitable for
the specific procedure for which it is to be used.
•
The catheter system should be used only by physicians trained
in the performance of arteriography and who have received
appropriate training in percutaneous transluminal angioplasty.
•
Consider the use of systemic heparinization. Flush all devices
entering the vascular system with sterile heparinized saline or
similar isotonic solution.
•
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.
PRO
VII. Adverse Effects
Possible adverse effects include, but are not limited to, the
following:
•
Air embolism
•
Aneurysm
•
Hematoma at the puncture site
•
Perforation of the vessel wall
•
Vascular Complications (e.g. intimal tear, dissection,
pseudoaneurysm, perforation, rupture, spasm, occlusion)
•
Embolism
•
Allergic reaction (device, contrast medium and medications)
•
Pyrogenic reaction
•
Hemorrhage, including bleeding at puncture site
•
Hypotension / hypertension
•
Ischemia
•
Necrosis
•
Thrombosis
VIII. Instructions for Use
Note: Do not use with Lipiodol contrast media, or other such
contrast media, which incorporate the components of these
agents.
Note: Do not expose the catheter to organic solvents (e.g. alcohol).
Note: Do not use if the inner package is open or damaged.
Note: Do not resterilize. Exposure to temperatures above 54°C
(130°F) may damage the catheter.
Note: Store in a cool, dark, dry place.
Removal from Package
Open the pouch, grasp the hub and gently take the catheter out.
Preparation
1.
Attach a 3-way stopcock to the inflation port, which is marked
"BALLOON".
®
PRO PTA
2.
Attach a partially filled syringe with heparinized saline to
the stopcock, open the stopcock to the balloon and induce
negative pressure.
3.
Hold the syringe and proximal end of the catheter above the
distal end of the catheter, and hold the balloon vertically with
the balloon tip pointing down.
4.
While maintaining negative pressure close the stopcock to the
inflation port. Remove the syringe and purge the air.
5.
To ensure air contained in the balloon and inflation lumen
is removed, apply negative pressure twice as instructed and
repeat steps 2-4.
6.
Without twisting, slide the forming tube off the balloon.
7.
Prepare an angioplasty inflation system with a 50% solution of
contrast medium in sterile saline or similar solution.
8.
Purge the air from the inflation device.
9.
Connect the inflation device to the 3-way stopcock that is
connected to the catheter inflation port, open the stopcock to
the catheter and slowly fill the inflation lumen and the balloon
will slowly fill with diluted contrast medium.
Caution: Do not apply positive or negative pressure to the
balloon at this time.
Insertion, Inflations and Withdrawal
1.
Flush the "THRU" lumen with sterile heparinized saline or a
similar isotonic solution.
2.
Place the prepared catheter over a prepositioned guidewire
and advance the tip to the introduction site.
Note: Balloon inflation should be performed with the
guidewire extended beyond the catheter tip. It is strongly
recommended that the guidewire, the balloon catheter, or
both, remain across the lesion until the procedure is complete
and the dilatation system is to be removed from the vessel.
Note: To preserve the folded balloon shape during insertion
and catheter manipulation, maintain a vacuum on the inflation
lumen.
Caution: Fully deflate the balloon by inducing negative
pressure with the inflation system whenever the PTA catheter
is advanced or withdrawn. Do not advance or withdraw the
PTA catheter within the vasculature unless the catheter is
preceded by a guidewire.
3.
Carefully advance the catheter through a sheath or guide
catheter through the percutaneous entry site.
Note: Gentle counterclockwise rotation of the balloon may
ease introduction through the sheath or percutaneous entry
site.
Note: Perform all further catheter manipulations under
fluoroscopy.
4.
Carefully advance the catheter to the selected stenosis.
Caution: If strong resistance is met during advancement
or withdrawal of the catheter, discontinue movement and
determine the cause of resistance before proceeding. If the
cause of resistance cannot be determined, withdraw the entire
system.
5.
Using fluoroscopy and the radiopaque marker bands, position
the catheter at the appropriate location.
6.
When an acceptable position has been obtained, inflate the
balloon to achieve the desired dilatation.
Caution: Do not exceed the rated burst pressure. Higher
pressures may damage the balloon or catheter or overdistend
the selected artery.
Warning: Inflation at a high rate may damage the balloon.
7.
Deflate the balloon by pulling vacuum on the inflation syringe
or inflation device.
8.
Remove the vacuum (do not apply pressure) and carefully
withdraw and remove the catheter.
Note: Gentle counterclockwise rotation of the balloon may
ease withdrawal from the sheath or from the percutaneous
entry site. If the balloon cannot be withdrawn through the
sheath, withdraw the catheter and sheath as a unit.
IX. References
•
The physician should consult recent literature on current
medical practice on balloon dilatation.
X. Disclaimer of Warranty and Limitation of Remedy
There is no express or implied warranty, including without
limitation any implied warranty of merchantability or fitness for
a particular purpose, on the Cordis product(s) described in this
publication. Under no circumstances shall Cordis be liable for
any direct, incidental, or consequential damages other than as
expressly provided by specific law. No person has the authority
to bind Cordis to any representation or warranty except as
specifically set forth herein.
Descriptions or specifications in Cordis printed matter, including
this publication, are meant solely to generally describe the product
at the time of manufacture and do not constitute any express
warranties.
Cordis Corporation will not be responsible for any direct,
incidental, or consequential damages resulting from reuse of the
product.
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