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Advance Serenity™ 18
Hydrophilic PTA Balloon Dilatation
Catheter
CAUTION: U.S. federal law restricts this device to sale
by or on the order of a physician (or a properly licensed
practitioner).
Sterile: Sterilized with ethylene oxide gas. Nonpyrogenic.
Radiopaque.
For single use only. Do not autoclave.
Carefully read all instructions prior to use, failure to observe
all warnings and precautions may result in complications.
DEVICE NAME
The device brand name is Advance Serenity 18 Hydrophilic
PTA Balloon Dilatation Catheter.
DEVICE DESCRIPTION
The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation
Catheter is an over-the-wire (OTW) co-axial catheter system
designed for use with 0.018 inch (0.46 mm) wire guides. The
shaft of the Percutaneous Transluminal Angioplasty (PTA)
balloon catheter contains a distal balloon and manifold on
the proximal. The balloon has two radiopaque markers that
aid in the placement of the balloon within the stenosis.
The clearance between the inner and outer catheter shaft
acts as a passage for the inflation medium for balloon
expansion. The balloon and catheter shaft are coated with a
hydrophilic coating.
The proximal end of the catheter has a bifurcated manifold
and strain relief that allows for the use of the 0.018 inch
wire guide and the attachment of a balloon inflation device
via a standard luer connector. The inflation device is used
to inflate and deflate the balloon with a contrast medium.
The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation
Catheter is to be provided sterile (via ethylene oxide, EtO)
and is intended for single use only.
INTENDED USE
The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation
Catheter is indicated for the Percutaneous Transluminal
Angioplasty (PTA) of the peripheral vasculature in the iliac,
femoral, popliteal, infra-popliteal and renal arteries, and for
the treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae.
CONTRAINDICATIONS
No contraindications known for PTA procedure. The
Advance Serenity 18 Hydrophilic PTA Balloon Dilatation
Catheter is contraindicated for use in the coronary arteries,
the neurovasculature, and for the delivery of stents.
WARNINGS
•
This device is intended for single use only; do not reuse.
Do not re-sterilize, as this can compromise device
performance and increase the risk of cross contamination
due to inappropriate reprocessing.
•
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 in
Percutaneous Transluminal Angioplasty (PTA).
•
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 device unless the balloon is
fully deflated under vacuum.
2
•
If resistance is met during manipulation, determine the
cause of the resistance before proceeding.
•
Balloon pressure should not exceed the rated burst
pressure (RBP). Refer to the product label for device
specific information. The RBP is based on results of
in vitro testing. At least 99.9% of the balloons (with a
95% confidence) will not burst at or below their RBP. To
prevent over pressurization, use a pressure monitoring
device.
•
Inflation at a high rate may damage the balloon.
•
Use only clinically recommended balloon inflation
medium. Never use air or any gaseous medium to inflate
the balloon.
•
Do not use with Lipiodol contrast media, or other such
contrast media which incorporate the components of this
agent.
•
Do not use after the "use by date" specified on the
package.
•
Do not use, or attempt to straighten, a catheter if the
shaft has become bent or kinked; this may result in the
shaft breaking. Instead prepare a new catheter.
PRECAUTIONS
•
A thorough understanding of the principles, clinical
applications and risk associated with PTA is necessary
before using this product.
•
This device is not recommended for applications that may
require inflation higher than those recommended for this
catheter.
•
Do not use if package is open or damaged.
•
Prior to use, 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.
•
During the procedure, appropriate anti-coagulant
therapy must be provided to the patient as needed.
Anti-coagulant therapy should be continued for a period
of time to be determined by the physician after the
procedure.
•
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 indicated
on the package label. Do not attempt to pass the PTA
catheter through a smaller size introducer sheath than
indicated on the label.
•
Not intended for precise arterial blood pressure
monitoring.
•
Do not advance or withdraw the PTA catheter within the
vasculature unless the catheter is preceded by a wire
guide.
•
Do not use for procedures other than those indicated in
this Instructions for Use.
POTENTIAL ADVERSE EVENTS
Potential adverse events include but are not limited to:
•
Thrombus
•
Vessel dissection, perforation, rupture or spasm
•
Death
•
Abrupt closure
•
Acute myocardial infarction
•
Acute or subacute thrombosis
•
Additional intervention required (major, moderate)
•
Allergic reaction (device, contrast medium and
medications)
•
Amputation
•
Angina
•
Air embolization
•
Aneurysm/Pseudoaneurysm
•
Arteriovenous fistula
•
Coma
•
Embolization, which includes thromboembolization
(arterial, pulmonary)
•
Hematoma/Pseudoaneurysm at puncture site
•
Hemorrhage, including bleeding at puncture site
•
Hypotension/Hypertension
•
Inflammation/Endarteritis
•
Intimal tear
•
Ischemia, including tissue ischemia, steal syndrome and
necrosis
•
Neurological events, including peripheral nerve injury and
neuropathies
•
Occlusion
•
Organ failure (single, multiple)
•
Paralysis
•
Pyrogenic reaction
•
Renal failure
•
Seizures/Spasm
•
Sepsis/Infection/Pyrogen reaction/Fever
•
Shock
•
Stroke
•
Transient ischemic attack
•
Weakness/Discomfort
MATERIAL REQUIRED
•
Introducer sheath(s) in the appropriate size and
configuration for the selected vasculature. See product
label for specific device compatibility.
•
2-3 syringes (10-20 cc)
•
0.018 inch (0.46 mm) wire guide of appropriate length for
the vasculature selected
•
Contrast media diluted 1:1 with saline
•
Inflation device with manometer
•
Three-way stopcock
•
Luer-lock syringe
•
Wire guide introducer
DILATION CATHETER PREPARATION
a. Select the balloon catheter and confirm that the
labelling matches the desired size, and the product use
by date is not expired.
b. The catheter is packaged in a protective hoop and
pouch; carefully remove the catheter from the package.
c. Remove the balloon protector (sheath) and packaging
mandrel from the balloon.
d. The balloon catheter in deflated position contains tiny
air bubbles that should be purged prior to inserting
the balloon catheter. To do this, connect a three-way
stopcock to the inflation port fitting on the dilatation
catheter. Flush through the stopcock. Connect a luer-
lock syringe, partly filled with sterile normal saline and
contrast medium, to the stopcock. Orient the dilatation
catheter with the distal tip and the balloon pointing
in a downward vertical position. Pull back the plunger
and aspirate for 15 seconds until the air is completely
evacuated. Close the three-way stopcock. Release
the plunger. Disconnect the syringe and evacuate
the collected air. Reconnect the syringe and repeat
the operation a couple of times until the balloon is
completely free of air bubbles.
e. Flush the wire lumen with sterile saline.
f. Prior to inserting the catheter, activate the coating
by immersing the catheter in normal saline for
approximately 30-60 seconds, or gently wiping down
the catheter shaft with a gauze sponge saturated in
normal saline.
CAUTION: Do not wipe down the catheter surface with
dry gauze.
Inflation Device Connection to Catheter
a. To remove any air lodged in the distal luer fitting of
the inflation device, purge approximately 1ml (cc) of
contrast medium.
b. With the stopcock in the closed position, disconnect
the syringe used in preparation applying a slight
positive pressure. A meniscus of contrast medium
will appear in the balloon port when the syringe is
removed. Verify that a meniscus of contrast medium
is evident in both the dilatation catheter balloon port
(hub) and the inflation device connection. Securely
couple the inflation device to the balloon inflation port
of the balloon dilation catheter.
Use of Balloon Angioplasty Catheter
a. Insert a wire guide through the hemostatic valve
following the manufacturer's instructions or standard
practice. Advance the wire guide carefully into the
introducer sheath. When complete, withdraw the wire
guide and introducer, if used.
b. Attach a torque device to the wire guide, if desired.
Under fluoroscopy, advance the wire guide to the
desired vessel, then across the stenosis.
c. Remove the torque device and back load the distal tip
of the dilatation catheter onto the wire guide.
NOTE: To avoid kinking, advance the Advance Serenity 18
slowly, in small increments until the proximal end of the
wire guide emerges from the catheter.
NOTE: To preserve the folded balloon shape during
insertion and catheter manipulation, maintain a vacuum on
the inflation lumen.
d. Advance the catheter through the hemostatic valve
slowly, while the balloon is fully deflated. It should be
observed that the hemostatic valve is only closed as much
to prevent blood return yet permitting easy movements of
the dilatation catheter. If resistance is encountered, do not
advance the catheter through the adapter.
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