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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INSTRUCTIONS FOR USE
POTENTIAL COMPLICATIONS / ADVERSE
EFFECTS
The complications that may result from a
balloon dilatation procedure include:
Puncture related:
- Local hematoma
- Local hemorrhage
- Local or distal thromboembolic
episodes
- Thrombosis
- Arterio-venous fistula
- Pseudoaneurysm
- Local infections
Dilatation related
- Dissection in the dilated artery wall
- Perforation of the artery wall
- Prolonged spasms
- Acute re-occlusion necessitating
surgical intervention
- Restenosis of the dilated artery
Angiography related
- Hypotension
- Pain and tenderness
- Arrhythmias
- Sepsis/infection
- Systemic embolization
- Endocarditis
- Short-term hemodynamic deterioration
- Death
- Drug reactions
- Allergic reaction to contrast medium
- Pyrogenic reaction
PREPARATION TECHNIQUE
Prior to use, carefully examine the unit to
verify that the catheter or sterile package
has not been damaged in shipment.
As supplied, the balloon and the guide
wire lumen of the AMPHIRION DEEP PTA
catheter contains air. This air must be
displaced to make certain that only liquid
fills the balloon while the catheter is in the
bloodstream.
CAUTION: Do not use with Li piodol
contrast media, or other such contrast
0110081 Rev. 04
Medtronic, Inc., Minneapolis , MN
media, which incorporate the
components of these agents.
To displace air:
1. Flush out the lumen for the guide wire
with heparinized saline solution
through the wire lumen, marked
“WIRE”.
2. Fill a 10 cc syringe with approximately
4 cc of a mixture of contrast medium
and normal saline.
3. Attach syringe to the ball oon lumen,
marked "BALLOON".
4. Pull the syringe plunger to deflate the
balloon.
5. To inflate the balloon, point the
syringe and balloon tip downward
and inject the contrast medium and
saline mixture. Repeat this process
several times if necessary.
6. Repeat steps 4 and 5 to remove air
from the balloon and catheter
7. Deflate the balloon.
8. Looking proximal to distal, manually
refold the deflated balloon clockwise
around the catheter.
9. Replace the syringe with a
manometer controlled dilatation
system, which has been partially filled
with saline solution.
Continue this procedure until all air has
been displaced and the balloon is filled
only with contrast mixture.
CAUTION: Do not exceed rated burst
pressure during this process.
The AMPHIRION DEEP PTA catheter shaft is
coated with a hydrophilic coating. Prior to
inserting the catheter, activate the
coating by immersing the catheter in
normal saline for approximately 30-60
seconds, or wiping down the catheter
shaft with a saturated gauze sponge.
CAUTION: Do not wipe down the catheter
surface with dry gauze.
CATHETER INSERTION
The AMPHIRION DEEP PTA catheter can be
introduced percutaneously, via surgical
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INSTRUCTIONS FOR USE
cutdown, or through an appropriate sized
introducer sheath.
When inserting a catheter through a badly
scarred area, use of an introducer sheath
is recommended.
CAUTION: Do not advance the guide wire
or the balloon dilatation catheter if
resista nce is m et with out firs t deter mining
the cause of resistance and taking
remedial action.
NOTE: To avoid kinking, advance the
dilatation catheter slowly, in small
increments until the proximal end of the
guide wire emerges from the catheter.
BALLOON INFLATION
Under fluoroscopic guidance the balloon
should be advanced and positioned
across the lesion to be dilated. The
balloon should be inflated by means of an
inflation device. It is recommended that
an inflation device with a 10 cc or larger
syringe barrel with gauge is used when
inflating the AMPHIRION DEEP PTA
catheter.
The standard inflation medium is a 1:1
mixture of contrast medium and normal
saline.
CAUTION: Do not use air or any gaseous
substances as a balloon inflation medium.
BALLON DEFLATION AND REMOVAL
After PTA, the balloon catheter is pulled
back over the positioned guide wire. It is
importa nt to note that after the balloon
has been dilated several times, there may
be some resistance as it is pulled back into
the introducer.
After use, this product may be a potential
biohazard. Handle and dispose of all such
devices in accordance with accepted
medical practice and applicable local,
regional, and national laws and
regulations.
0110081 Rev. 04
Medtronic, Inc., Minneapolis , MN
HOW SUPPLIED
The AMPHIRION DEEP PTA catheter is
supplied sterile and intended for single use
only. The AMPHIRION DEEP PTA catheter is
sterilized by ethylene oxide gas. It will
remain sterile as long as the packaging
remains unopened and undamaged. Use
product prior to labeled Use Before date.
CAUTION: Do not use if the inner package
is open or damaged.
STORAGE
Store at controlled room temperature in
dry place. Do not expose to organic
solvents (e.g. alcohol), ionizing radiation or
ultravi olet l ight. Ro tate inventory so that
catheters are used prior to the Use Before
date on package label.
WARRANTY DISCLAIMER
Although this product has been
manufactured under carefully controlled
conditions, Invatec has no control over the
conditions under which this product is
used. Invatec therefore disclaims all
warranties, both express and implied, with
respec t to the product, inclu ding, but not
limited to, any implied warranty of
merchantability or fitness for a particular
purpose. Invatec shall not be liable to any
person or entity for any medical expenses
or any direct, incidental or consequential
damages caused by any use, defect,
failure or malfunction of the product,
whether a claim for such damages is
based upon warranty, contract, tort or
otherwise. No person has any authority to
bind Invatec to any representation or
warranty with respect to the product.
The exclusions and limitations set out
above are not intended to, and should
not be construed so as to contravene
mandatory provisions of applicable law. If
any part or term of this Disclaimer of
Warranty is held to be illegal,
unenforceable or in conflict with
applicable law by a court of competent
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Manufacturer
INSTRUCTIONS FOR USE
jurisdiction, the validity of the remaining
portions of this Disclaimer of Warranty shall
not be affected, and all rights and
obligations shall be construed and
enforced as if this Disclaimer of Warranty
did not contain the particular term held to
be invalid.
0110081 Rev. 04
Medtronic, Inc., Minneapolis , MN
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Manufacturer
INSTRUCTIONS FOR USE
0110081 Rev. 04
Medtronic, Inc., Minneapolis , MN
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Manufacturer
INSTRUCTIONS FOR USE
© 2014 Medtronic, Inc.
Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
www.medtronic.com
Tel. (888) 283-7868
Fax (800) 838-3103
USA
*0110081*
Rev. 04
0110081 Rev. 04
Medtronic, Inc., Minneapolis , MN
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Manufacturer
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