English - Abbott Armada 14 XT Manual Del Usuario

Armada 14 XT
Percutaneous Transluminal
Angioplasty (PTA) Catheter
CAUTION
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE.
OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED
THROUGHOUT THESE INSTRUCTIONS. FAILURE TO DO SO
MAY RESULT IN COMPLICATIONS.
DESCRIPTION
The Armada 14 XT Percutaneous Transluminal Angioplasty
(PTA) Catheter is an over-the-wire system comprised of a
two-lumen catheter with a balloon near the distal tip. One
lumen is used for inflation of the balloon with contrast medium.
The second lumen permits the use of a guide wire to facilitate
advancement of the PTA catheter to and through the stenosis
to be dilated, and the injection of contrast and / or medication
through the distal tip. The PTA catheter is coated with
HYDROCOAT hydrophilic coating that is activated when wet.
This device has several markers. The balloon has radiopaque
marker(s) 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. The proximal shaft
has proximal markers that aid in gauging the PTA catheter
position relative to the sheath / guiding catheter tip (marker
located closest to the PTA catheter adapter is for femoral
guiding catheters and the other marker is for brachial guiding
catheters).
The two-arm adapter on the proximal end of the PTA catheter
provides access to the inflation lumen and the guide wire
lumen. The side arm connects with the inflation lumen and has
a Luer lock fitting for connecting the PTA catheter to an inflation
device. The central arm connects with the guide wire lumen,
which allows for free movement of the inserted guide wire.
HOW SUPPLIED
Sterile – This device is sterilized with ethylene oxide gas. Non-
pyrogenic. Do not use if the package is open or damaged.
This single use device cannot be reused on another patient,
as it is not designed to perform as intended after the first
usage. Changes in mechanical, physical, and / or chemical
characteristics introduced under conditions of repeated use,
cleaning, and / or resterilization may compromise the integrity
of the design and / or materials, leading to contamination due
to narrow gaps and / or spaces and diminished safety and / or
performance of the device. Absence of original labeling may
lead to misuse and eliminate traceability. Absence of original
packaging may lead to device damage, loss of sterility, and risk
of injury to the patient and / or user.
Contents – One (1) Armada 14 XT PTA Catheter, one (1)
protective sheath, and one (1) compliance card
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English

Storage – Store in a dry, dark, cool place.
INDICATIONS
The Armada 14 XT PTA Catheter is indicated to dilate stenosis
in femoral, popliteal, infrapopliteal and renal arteries and for
the treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. The 2.0 mm to 5.0 mm balloon
diameters are also indicated for post-dilatation of stents in the
peripheral vasculature.
CONTRAINDICATIONS
The Armada 14 XT PTA Catheter is contraindicated for:
• Inability to cross lesion with a guide wire
WARNINGS
This device is intended for one time use only. DO NOT
resterilize and / or reuse it, as this can compromise device
performance and increase the risk of cross contamination due
to inappropriate reprocessing.
Any use for procedures other than those indicated in these
instructions is not recommended.
Precautions to prevent or reduce clotting should be taken when
any catheter is used.
The size of the inflated balloon should be selected not to exceed
the diameter of the artery immediately distal, or proximal, to
the stenosis.
Balloon pressure should not exceed the rated burst pressure
(RBP). 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. Use of a pressure-monitoring device is
recommended to prevent over-pressurization.
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.
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.
Do not torque the catheter more than one (1) full turn.
If a distal protection device is used, follow the manufacturer's
instruction for use. Allow and maintain adequate distance
between the Armada 14 XT PTA Catheter and the distal
protection device to avoid engagement.
Use only the recommended balloon inflation medium. Never use
air or any gaseous medium to inflate the balloon.
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 resistance before
proceeding.
Treatment of moderately or heavily calcified lesions increases
the risk of acute closure, vessel trauma, balloon burst, balloon
entrapment, and associated complications. If resistance is felt,
determine the cause before proceeding. Continuing to advance
or retract the catheter while under resistance may result in
damage to the vessels and / or damage / separation of the
catheter.
In the event of catheter damage / separation, recovery of any
portion should be performed based on physician determination
of individual patient condition and appropriate retrieval protocol.
In cases of extreme vessel tortuosity, it may be necessary to
reposition the catheter in a straight segment of the vessel in
order to allow guide wire exchange. Do not continue to use
a catheter if excessive resistance is felt during guide wire
exchanges. Instead, prepare a new catheter.
PRECAUTIONS
This device should only be used by physicians who are
experienced and have a thorough understanding of the clinical
and technical aspects of PTA.
Note the "Use by" date specified on the package.
Inspect all product prior to use. Do not use if the package is
open or damaged.
Prior to angioplasty, the PTA catheter should be examined to
verify functionality and ensure that its size is suitable for the
specific procedure for which it is to be used.
Precautions to prevent or reduce clotting should be taken when
any catheter is used.
Flush or rinse all products entering the vascular system with
sterile heparinized normal saline or a similar solution via
the guide wire access port prior to use. Consider the use of
systemic heparinization.
Never attempt to move the guide wire when the balloon is
inflated.
The minimal acceptable sheath / guiding catheter French size
is printed on the package label. Do not attempt to pass the
Armada 14 XT PTA Catheter through a smaller sized sheath /
guiding catheter than indicated on the label.
If the surface of the Armada 14 XT PTA Catheter becomes
dry, wetting with heparinized normal saline will reactivate the
coating.
Do not reinsert the Armada 14 XT PTA Catheter into the coil
dispenser after procedural use.
Bench testing was conducted with 0.014" (0.36 mm) constant
diameter guide wires to establish guide wire compatibility. If
another type of guide wire is selected with a different
dimensional profile, the compatibility (e.g., wire resistance)
should be considered prior to use.
The safety and effectiveness of this PTA balloon catheter
for the treatment of in-stent restenosis (ISR) have not been
established.
ADVERSE EVENTS
Possible adverse effects include, but are not limited to, the
following:
• Abrupt closure
• Access site hematoma
• Aneurysm
• Angina
• Arrhythmias
• Arteriovenous fistula
• Bleeding complications, which may require transfusion
• Cerebral ischemia / transient ischemic attack (TIA)