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PPE Specification
Labeling Specification
IFU
English
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® PRO 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® PRO PTA catheter is
contraindicated for use in coronary arteries.
V. Warnings
•
This product is designed and intended for single use. It is not designed
to undergo reprocessing and re-sterilization after initial use. Reuse
of this product, including after reprocessing and/or re-sterilization,
may cause a loss of structural integrity which could lead to a failure
of the device to perform as intended and may lead to a loss of critical
labeling/use information all of which present a potential risk to patient
safety.
•
To reduce the potential for vessel damage or the risk of dislodgement
of particles it is very important that the inflated diameter of the
balloon should approximate the diameter of the vessel just proximal
and distal to the lesion. The balloon dimensions are printed on the
product label. The compliance table incorporated with the product
shows how balloon diameter increases as pressure increases.
•
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.
•
If resistance is felt upon removal, then the balloon, guidewire and the
sheath should be removed together as a unit, particularly if balloon
rupture or leakage is known or suspected.
•
Do not exceed the rated burst pressure recommended on the label.
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 (a 50/50 mixture
by volume of contrast medium and normal saline). Never use air or any
gaseous medium to inflate the balloon.
•
Use the catheter prior to the "Use By" date specified on the package.
•
Do not use Ethiodol or Lipiodol contrast media.
•
Pressure in excess of the rated burst pressure can cause balloon
rupture and potential inability to withdraw the catheter through the
introducer sheath. Balloon rupture can cause vessel damage and the
need for additional intervention.
•
Proper functioning of the catheter depends on its integrity. Care
should be used when handling the catheter. Damage may result
from kinking, stretching, or forceful wiping of the catheter. Forceful
handling can result in catheter separation and the subsequent need
to use a snare or other medical interventional techniques to retrieve
the pieces.
•
Always verify integrity of the catheter after removal.
•
Maintain a snug seal with the hemostasis valve over the balloon
catheter during advancement to prevent introduction of air into the
sheath or guiding catheter. Without a snug seal, a tight fit between
the balloon section of the balloon catheter and the sheath or guiding
catheter may cause a risk for introduction of air and air entrainment
during advancement of the balloon catheter through the sheath or
guiding catheter.
•
Prior to angioplasty, the catheter should be examined to verify
functionality and integrity, and ensure that its size and shape are
suitable for the specific procedure for which it is to be used. Do not
use if product damage is evident.
•
The minimal acceptable sheath introducer/guiding catheter size
is printed on the package label. Do not attempt to pass the PTA
catheter through smaller size sheath introducer/guiding catheter
than indicated on the label. Use of a smaller than indicated
accessory device can lead to introduction of air into that device
as the balloon catheter is advanced, which may not be removed
during air aspiration.
VI. Precautions
•
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. Prior to use, ensure all devices have been
flushed and air is removed from the system according to standard
medical practice. Failure to do so could result in air entering the
vascular system.
•
Caution should be taken when treating patients with poor renal
function who, in the physician's opinion, may be at risk for a
contrast medium reaction.
•
During the procedure remove blood or any other residues from the
devices, using a heparinized-saline soaked gauze.
•
Not intended for precise arterial blood pressure monitoring.
VII. Adverse Effects
Possible adverse effects include, but are not limited to, the following:
•
Abrupt vessel closure
•
Additional intervention
•
Acute myocardial infarction
•
Allergic reaction (device, contrast medium and medications)
•
Amputation
•
Arrhythmias
•
Arteriovenous fistula
•
Death
•
Embolism
•
Hematoma at puncture site
•
Hemorrhage
•
Hypotension / hypertension
•
Inflammation/ infection/ sepsis
•
Ischemia
•
Necrosis
•
Neurological events , including peripheral nerve injury, transient
ischemic attack and/ or stroke
•
Organ failure (single, multiple)
•
Pain
•
Paralysis
•
Pseudoaneurysm
•
Renal failure
•
Restenosis of the dilated vessel
•
Thrombosis
•
Vascular complications (e.g. intimal tear, dissection, pseudoaneurysm,
perforation, rupture, spasm, occlusion)
VIII. Instructions for Use
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".
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.
Released: 23 Feb 2022
Release Level: 4. Production
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.
Français
STERILE. Stérilisé par gaz d'oxyde éthylène. Apyrogène. Radio‑
opaque. A usage unique. Ne pas restériliser.
I.
Désignation du dispositif
La désignation commerciale du dispositif est cathéter pour Angioplastie
Transluminale Percutanée (PTA) POWERFLEX® PRO de Cordis. Son
appellation générique est cathéter PTA de dilatation par ballon.
II. Description
Le cathéter pour Angioplastie Transluminale Percutanée (PTA)
POWERFLEX® PRO de Cordis est un cathéter qui est doté en sa partie
distale d'un ballonnet gonflable muni de deux bandes radio-opaques
qui en indiquent le segment utile et aident à positionner le dispositif.
L'extrémité du cathéter est fuselée pour faciliter son introduction dans les
artères périphériques et dans les sténoses étroites.
La pression d'utilisation du ballonnet se situe entre la pression nominale
et la pression d'éclatement évaluée. Tous les ballonnets dépassent leur
diamètre nominal pour une pression supérieure aux valeurs de pression
nominale indiquées ci-dessous. Se reporter au tableau porté sur l'étiquette
pour les diamètres types des ballonnets aux différentes pressions de
gonflage.
La lumière de ballonnet, marquée "BALLOON", est utilisée pour gonfler et
pour dégonfler le ballonnet. Le diamètre nominal du ballonnet est imprimé
sur l'embout. La voie d'injection marquée "THRU" est destinée au passage
12150628 | Rev:11
CO: 100594664
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