Pacific™ Plus
PTA Catheter
Instructions for Use
Caution: Federal (USA) law restricts this product for sale by or on the
order of a physician.
Trademarks
Trademarks may be registered and are the property of their respective owners.
Explanation of symbols on package labeling
Manufacturer
Manufactured In
Keep Dry
Keep Away F rom Sun light
Do Not Reuse
Do Not Resterilize
Do Not Use if Package is Damaged
Caution
Consult Instructions for Use
Use By
Nonpyrogenic
Caution: Federal (USA) law restricts this product for sale by or on the
order of a physician.
Quantity
Do Not Exceed Rated Burst Pressure
Catalogue Number
1
Lot Number
Sterilized Using Ethylene Oxide
Over The Wire
Nominal Pressure
Rated Burst Pressure
Maximum Guidewire Diameter
Minimum Sheath Inner Diameter
Inflation Pressure
Balloon Diameter
Balloon Length
Usable Catheter Length
2
Pacific™ Plus
PTA Catheter
1.0 DESCRIPTION
The Pacific™ Plus PTA catheter is an overthe-wire (OTW) peripheral balloon catheter,
specifically designed for percutaneous
transluminal angioplasty (PTA) in stenosed
vessel segments. The catheter is a coaxial
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 guidewire
with a maximum outer diameter of 0.018 in
(0.46 mm). 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.
Consult the Compliance Chart included in the
catheter packaging for the diameters of the
balloons at given pressures. The Pacific Plus
PTA catheter is available in different balloon
sizes and is provided with a hydrophilic
coating. The balloon length is specified on the
package label.
The Pacific Plus PTA catheter does not
contain natural rubber latex. However, during
the manufacturing, assembly, or packaging
process, it may have incidental contact with
materials, tools, or equipment containing or
coming in contact with latex.
2.0 INDICATIONS FOR USE
The Pacific Plus PTA catheter is intended to
dilate stenoses in the iliac, femoral,
iliofemoral, popliteal, infrapopliteal, and renal
arteries, and for the treatment of obstructive
lesions of native or synthetic arteriovenous
dialysis fistulae.
3.0 CONTRAINDICATIONS
The Pacific Plus PTA catheter is
contraindicated for use in coronary arteries or
the neurovasculature. It is also
contraindicated when the guidewire is unable
to cross the target lesion.
4.0 WARNINGS
■
This device is designed and intended for
single use only. DO NOT RESTERILIZE
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
transmission 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 PTA balloon in an
inflated state. The position of the PTA
balloon may only be changed with the
guidewire in place.
■
If resistance occurs during manipulation,
determine the cause using fluoroscopy,
roadmapping, or DSA before moving the
catheter backward or forward.
■
The guidewire may under no
circumstances be moved during inflation
of the balloon.
■
The balloon must be completely deflated
before removing the catheter from the
vascular system.
3 Instructions for Use
■
Do not exceed the rated burst pressure
(RBP). 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. Inflation in excess of the
rated burst pressure may cause the
balloon to rupture.
■
Use a 1:1 or 1:3 mixture of contrast
medium and saline solution to fill the
balloon. (It has been shown that a
1:3 ratio yields faster balloon inflation/
deflation times.) Never use air or any
gaseous medium to inflate the balloon.
■
Use the catheter prior to the Use By date
noted on the package.
■
Do not expose to organic solvents (such
as alcohol), ionizing radiation, or
ultraviolet light.
5.0 PRECAUTIONS
■
Only Interventionalists who have
sufficient experience should carry out
percutaneous transluminal angioplasty
with this balloon dilatation catheter. A
thorough understanding of the technical
principles, clinical applications, and risks
associated with PTA is necessary before
using this product.
■
Appropriate drug therapy (anticoagulant,
vasodilator, etc.) should be administered
to the patient according to standard
protocols for PTA before insertion of the
balloon dilatation catheter.
■
Exercise care during handling to avoid
possible damage to the catheter. Do not
use a catheter that has been damaged.
■
To minimize the possible introduction of
air into the system, before proceeding
pay careful attention to the maintenance
of tight catheter connections throughout
aspiration and flushing of the system.
■
Exercise caution when using the Pacific
Plus PTA catheter for procedures with
calcified lesions due to the abrasive
nature of these lesions.
■
Allergic reactions to contrast medium
should be identified before treatment.
■
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. Select the
technique to be used based on the
patient’s condition and the experience of
the interventionalist.
■
The maximum diameter of the guidewire
must not exceed 0.018 in (0.46 mm).
Certain coatings on guidewires may lead
to increased friction between the
guidewire and the catheter.
6.0 ADVERSE EFFECTS
Complications associated with the use of the
Pacific Plus PTA catheter are similar to those
associated with standard PTA procedures.
Possible complications may include, but are
not limited to:
Puncture related:
■
Arteriovenous fistula
■
Local hematoma
■
Local hemorrhage
■
Local infections
■
Local or distal thromboembolic episodes
■
Pseudoaneurysm
■
Thrombosis
Dilatation related:
■
Acute reocclusion necessitating surgical
intervention
■
Dissection in the dilated artery wall
■
Perforation of the artery wall
■
Prolonged spasms
■
Restenosis of the dilated artery
■
Total occlusion of the peripheral artery
Angiography related:
■
Allergic reaction to contrast medium
■
Arrhythmias
■
Death
■
Drug reactions
■
Endocarditis
■
Hypotension
■
Pain and tenderness
■
Sepsis/infection
■
Short-term hemodynamic deterioration
■
Systemic embolization
Instructions for Use 4
7.0 INSTRUCTIONS FOR USE
7.1 INFLATION DEVICE PREPARATION
Prepare the inflation device according to the
manufacturer's instructions.
7.2 CATHETER SELECTION
1. The nominal balloon size must be
chosen equal to or smaller than the inner
diameter of the artery proximal and distal
to the lesion.
2. If the stenosis cannot be crossed with
the desired catheter, use a smaller
catheter to predilate the lesion and
facilitate the passage of a more
appropriately-sized catheter.
7.3 PREPARATION TECHNIQUE
Caution: Avoid manipulating the catheter
while removing it from the packaging and
flushing the guidewire lumen.
1. Prior to use, carefully examine the unit to
verify that the catheter or sterile package
has not been damaged in shipment.
2. The catheter is packaged in a protective
coil. Gently remove it from the hoop.
3. After moistening the balloon protection
sheath with physiological saline solution,
carefully remove the balloon protection
sheath without damaging the balloon.
Caution: Do not use with Lipiodol or
Ethiodol contrast media, or other such
contrast media that incorporate the
components of these agents.
7.4 TO DISPLACE AIR
1. Flush out the guidewire lumen by
connecting a syringe filled with saline
solution. Start flushing until liquid rinses
out of the guidewire lumen at the distal
tip of the catheter.
2. Connect a syringe contai ning co ntrast
medium to the luer connector located at
the proximal hub of the catheter and
apply negative pressure for
approximately 15 seconds until no
bubbles appear in the contrast medium
solution. Return to atmospheric
pressure, allowing contrast medium flow
into the catheter lumen. Remove the
syringe, leaving a meniscus of contrast
medium in the hub of the balloon lumen.
3. Remove air bubbles from the inflation
device following the manufacturer’s
instructions.
4. Using the stopcock, attach the inflation
device to the catheter. Do not allow air to
enter the system.
Note: The Pacific Plus PTA catheter is
provided with a hydrophilic coating. Prior to
inserting the catheter, activate the coating by
immersing the catheter in normal saline for
approximately 5 seconds or wiping down the
catheter shaft with a saline-saturated gauze.
Caution: Do not wipe down the catheter
surface with a dry gauze.
7.5 INSERTION TECHNIQUE
Note: Access to the vessel must be
sufficiently patent, or sufficiently recanalized,
to proceed with further intervention.
1. If the guidewire has not already been
positioned across the lesion, under
fluoroscopy insert a 0.018 in (0.46 mm)
or 0.014 in (0.36 mm) guidewire across
the lesion following standard PTA
techniques.
2. Insert the proximal end of the guidewire
into the distal tip of the catheter.
3. Carefully insert the catheter through the
introducer sheath and, under
fluoroscopic guidance, carefully
advance it through the peripheral
vasculature following the guidewire
toward the lesion.
Caution: Do not advance the guidewire or
the catheter if resistance is met without first
determining the cause of resistance and
taking remedial action.
4. Carefully position the balloon within the
lesion using the 2 radiopaque markers
located under the balloon as reference
points for precise placement across the
target lesion.
5. If the stenosis cannot be crossed with
the desired dilatation catheter, use a
smaller diameter catheter to predilate
the lesion and facilitate passage of a
more appropriately-sized dilatation
catheter.
Note: To avoid kinking, advance the catheter
slowly in small increments until the proximal
end of the guidewire emerges from the
catheter.
5 Instructions for Use
7.6 BALLOON INFLATION
1. Make sure all air bubbles are removed
from the catheter and the inflation device
before inflating the balloon.
2. Open the stopcock on the inflation
device. Inflate the balloon gradually to
dilate the lesion to the calculated
diameter in accordance with the
Compliance Chart.
3. 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.
Caution: Do not inflate the balloon more
than 10 times at the RBP.
4. Apply a constant pressure for
approximately 30 seconds.
Caution: Do not exceed the rated burst
pressure (RBP).
7.7 BALLOON DEFLATION AND
REMOVAL
Caution: Larger models of the Pacific Plus
PTA catheter may exhibit slower deflation
times, particularly on long catheter shafts.
1. Deflate the balloon in accordance with
standard PTA procedures. Apply
negative pressure to the balloon for at
least 60-120 seconds. Ensure the
balloon is fully deflated under
fluoroscopy before carefully removing
the catheter from the vessel.
2. Carefully remove the deflated balloon
from the introducer while maintaining
negative pressure.
3. 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.
8.0 HOW SUPPLIED
The Pacific Plus PTA catheter is supplied
sterile and intended for single use only. It is
sterilized by ethylene oxide gas and it will
remain sterile as long as the packaging
remains unopened and undamaged. Use
product prior to Use By date.
Caution: Do not use if the inner package is
open or damaged.
9.0 STORAGE
Store at controlled room temperature, in a dry
place. Keep product away from sunlight. Do
not expose to organic solvents (such as,
alcohol), ionizing radiation, or ultraviolet light.
Rotate inventory so that catheters are used
prior to the expiration date on package label.
10.0 DISCLAIMER OF WARRANTY
NOTE: ALTHOUGH THE MEDTRONIC
PACIFIC PLUS PTA CATHETER,
HEREAFTER REFERRED TO AS
"PRODUCT," HAS BEEN MANUFACTURED
UNDER CAREFULLY CONTROLLED
CONDITIONS, MEDTRONIC, INC.,
MEDTRONIC VASCULAR, INC., AND THEIR
AFFILIATES (COLLECTIVELY,
"MEDTRONIC") HAVE NO CONTROL OVER
CONDITIONS UNDER WHICH THIS
PRODUCT IS USED. MEDTRONIC,
THEREFORE, DISCLAIMS ALL
WARRANTIES, BOTH EXPRESSED AND
IMPLIED, WITH RESPECT TO THE
PRODUCT, INCLUDING, BUT NOT LIMITED
TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. MEDTRONIC
SHALL NOT BE LIABLE TO ANY PERSON
OR ENTITY FOR ANY MEDICAL EXPEN SES
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 MEDTRONIC 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
jurisdiction, the validity of the remaining
portions of this Disclaimer of Warranty shall
not be affected.
Instructions for Use 6
Manufacturer:
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
U.S. CUSTOMER SERVICE/
PRODUCT INQUIRIES:
Tel. (888) 283-7868
Fax (800) 838-3103
*0110106-00*
© 2012 Medtronic, Inc.
0110106-00
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