Medtronic AMP015020001 Instructions for Use
INSTRUCTIONS FOR USE
CAUTION: Federal (USA) law restricts this product for sale by or on the order of a
physician.
0110081 Rev. 04
Medtronic, Inc., Minneapolis , MN
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Manufacturer
INSTRUCTIONS FOR USE
DESCRIPTION
The AMPHIRION™ DEEP percutaneous
transluminal angioplasty (PTA) balloon
dilatation catheter i s a cathe ter wi th a
semi-compliant inflatable balloon
mounted at the d istal tip. Dil atation
balloon catheters are used to exert radial
force to dilate narrow vessel segments.
The AMPHIRION™ DEEP PTA catheter is
available in different balloon sizes.
Nominal balloon diameter and length are
printed on the hub.
BALLOON CONSTRUCTION
Each balloon inflates to its nominal
diameter and length at 7ATM. 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 Charts included in the
catheter packaging for the diameters of
the balloons at given pressures.
Note: The rated burst pressure is printed on
the package label. In vitro testing has
shown that with 95% confidence, 99.9% of
the balloons will not burst at or below the
rated burst pressure. Balloons should not
be inflated in excess of the rated burst
pressure. The nominal balloon diameters
were measured in vitro and can present a
maximum statistical deviation of ±10%.
A single central radiopaque marker or 2
radiopaque markers are available in order
to correctly position the balloon under
fluoroscopy. The markers are placed on
the shaft under the balloon itself, defining
its cylindrical area in the double marker
version and placed in the middle of the
cylindrical area in the single marker
version. The catheter tip is tapered to ease
entry into peripheral arteries and to
facilitate the crossing of tight stenoses.
0110081 Rev. 04
Medtronic, Inc., Minneapolis , MN
CATHETER CONSTRUCTION
The AMPHIRION™ DEEP PTA balloon
dilatation catheter is a dual lumen device.
The lumen marked "WIRE" is the central
lumen of the catheter, which terminates at
the distal tip. This lumen is used to pass the
catheter over a guide wire with a
maximum outer diameter of 0.014 in. The
lumen marked "BALLOON" is the balloon
inflation lumen, which is used to inflate
and deflate the dilatation balloon with a
mixture of contrast medium and saline
solution. The catheter tapers beneath the
balloon segment to achieve the lowest
possible deflated profile.
One or 2 radiopaque marker bands are
placed under the balloon segment of the
catheter shaft to provide visual reference
points for balloon positioning within the
vessel. The distal catheter shaft is
hydrophilic coated (balloon included).
INDICATIONS FOR USE
The AMPHIRION DEEP PTA balloon
dilatation catheter up to 120 mm balloon
length is intended to dilate stenoses in the
iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the
treatment of obstructive lesions of native
or synthetic arteriovenous dialysis fistulae.
The AMPHIRION DEEP PTA balloon
dilatation catheter in 150 mm and 210 mm
balloon length is intended to d ilate
stenoses in the femoral, popliteal, and
infra-popliteal arteries.
CONTRAINDICATIONS
Inability to cross target lesion with a guide
wire.
The AMPHIRION DEEP PTA balloon dilation
catheter is contraindicated for use in
coronary arteries or the neurovasculature.
WARNINGS
- This device is designed and intended
for single use only. DO NOT RESTERILIZE
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INSTRUCTIONS FOR USE
AND/OR REUSE. Reuse or resterilization
may create a risk of contamination of
the device and/or cause patient
infection or crossinfection, including,
but not limited to , the transmiss ion of
infectious disease(s) from one patient
to another. Contamination of the
device may lead to injury, illness, or
death of the patient. Reuse or
resterilization may compromise the
structural integrity of the device and/or
lead to device failure, which, in turn,
may result in patient injury, illness, or
death. Medtronic will not be
responsible for any direct, incidental, or
consequential damages resulting from
resterilization or reuse.
- 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 manipulate the balloon in
inflated state. The position of the
balloon catheter may only be
changed with the guide wire in place.
- If resistance occurs during
manipulation, the cause must first be
ascertained by fluoroscopy, road
mapping or DSA before the balloon is
moved backwards or forwards.
- The guide wire may under no
circumstances be moved during
inflation of the balloon.
- The balloon must be completely
deflated before pulling it out of the
dilated area.
- Balloon pressure should not exceed the
rated burst pressure. The rated burst
pressure is based on the results of invitro tes ting. A t least 99.9% of th e
0110081 Rev. 04
Medtronic, Inc., Minneapolis , MN
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 a mixture of contrast medium
and saline solution to fill the balloon
(1:1). Never use air or any gaseous
medium to inflate the balloon.
- Use the catheter prior to the Use Before
date specified on the package.
PRECAUTIONS
- Only interventionalists wh o have
sufficient experience should carry out
PTA with this balloon catheter. A
thorough understanding of the
technical principles, clinical
applications and risks associated with
percutaneous transluminal angioplasty
is necessary before using this product.
- AMPHIRION DEEP PTA balloon dilatation
catheters should be used with caution
for procedures involving calcified
lesions or synthetic vascular grafts due
to the abrasive nature of these lesions.
- Allergic reactions to contrast medium
should be identified before PTA.
- The general technical requirements for
catheter insertion must be observed at
all times. This includes flushing the
components with sterile, isotonic saline
solution prior to use and the usual
prophylactic, systemic heparinization.
- Catheter applications vary and the
technique must be selected on the
basis of the patient’s condition and the
experience of the interventionalist.
CAUTION: Larger models of AMPHIRION
DEEP PTA balloon dilatation catheters
may exhibit slower deflation times
particularly on long catheter shafts.
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