BD UltraScore Gebrauchsanweisung Seite 2

• Hemorrhage or bleeding
• Hemothorax
• High blood pressure, hypertension
• Hypersensitivity, allergic reaction
• Infection
• Inflammation
• Low blood pressure, hypotension
• Pain
• Perforation of vessel
• Peripheral arterial ischemia
• Peripheral arterial occlusion - renal or limb
• Peripheral arterial thrombosis - renal or limb
• Pneumothorax
• Prolonged surgery
• Shock
• Stroke
• Vessel dissection
• Vessel spasm
Note: Users and/or patients within the European Union, should report any serious incident that
has occurred in relation to the device to the manufacturer and the competent authority of the
Member State in which the user and/or patient is established.
Users outside of the European Union should report any serious incident that has occurred in
relation to the device to the manufacturer and the regulatory authority of the country in which
the user and/or patient is established.
Directions for Use
Handling & Storage
Keep away from sunlight. Keep dry. Protect from heat and radioactive sources. Rotate
inventory so that the catheters and other dated products are used prior to the "Use By" date.
Do not use if packaging is damaged or opened.
Equipment Required
• Contrast medium
• Sterile saline solution
• Luer lock syringe/inflation device with manometer (10 ml or larger)
• Appropriate introducer sheath and dilator set
• .014" or .035" guidewire
• Optional: Catheter stabilization device
Dilatation Catheter Preparation
1. Remove the balloon catheter from package. Do not use the device if the sterile packaging
has been damaged or unintentionally opened prior to use. Examine the catheter to ensure it
has not been damaged during shipment and that its size, shape and condition are suitable
for the procedure for which it is to be used. Do not use if product damage is evident. Verify
the selected accessories accommodate the catheter as labeled.
2. Remove the stylet and protective sheath by grasping the balloon catheter just proximal to
the balloon and with the other hand, gently grasp the mandrel and sheath protector and
slide distally off of the balloon catheter.
Precaution: While removing the protective sheath, care should be taken to avoid damaging the
balloon catheter.
3. Prior to use, the air in the balloon catheter should be removed. To remove air, first select a
syringe or inflation device with a 10 ml or larger capacity and fill approximately half of it with
the appropriate balloon inflation medium (25% contrast medium/75% sterile saline solution).
Do not use air or any gaseous medium to inflate the balloon.
4. Connect a stopcock to the balloon inflation female luer hub on the dilatation catheter.
5. Connect the syringe to the stopcock.
6. Hold the syringe with the nozzle pointing downward, open the stopcock and aspirate for
approximately 15 seconds. Release the plunger.
7. Repeat step #6 two more times or until bubbles no longer appear during aspiration (negative
pressure). Once completed, evacuate all air from the barrel of the syringe/inflation device.
8. In order to activate the coating, wet the balloon catheter with sterile saline or wipe the
balloon catheter with saline saturated gauze immediately prior to its insertion in the
introducer sheath.
9. Prepare the wire lumen of the catheter by attaching a syringe to the wire lumen hub and
flushing with sterile saline solution.
Precaution: Do not wipe the balloon catheter with dry gauze.
Use of the U S Focused Force PTA Balloon
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1. Backload the distal tip of the U
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positioned guidewire and advance the tip to the introduction site.
2. Advance the catheter through the introducer sheath/guide catheter and over the wire to
the site of inflation. If the stenosis cannot be crossed with the desired dilatation catheter,
use a smaller diameter catheter to pre-dilate the lesion to facilitate passage of a more
appropriately sized dilatation catheter.
Note: If using a hydrophilic guidewire, ensure that it is kept hydrated with sterile normal saline
at all times.
3. Position the balloon relative to the lesion to be dilated, ensure the guidewire is in place and
slowly inflate the balloon with an inflation device.
Note: Balloon lengths 100mm and longer have two marker bands located at the distal portion
of the working length of the balloon and one marker band at the proximal portion. The working
length of the balloon is measured at the proximal edge of the proximal marker band to the distal
edge of the most distal marker band.
Precaution: Do not inflate the balloon past its labeled rated burst pressure.
4. Apply negative pressure to fully evacuate fluid from the balloon. Confirm that the balloon is
fully deflated under fluoroscopy and that no contrast is left in the balloon.
S Focused Force PTA Balloon over the pre-
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core
5. While maintaining negative pressure and the position of the guidewire, grasp the balloon
catheter just outside the introducer sheath/guide catheter and withdraw the deflated
dilatation catheter over the wire through the introducer sheath/guide catheter.
Optional: To ensure that the sheath does not move during the procedure, use a catheter
stabilization device to stabilize the sheath at the access site.
Optional: When used as a location reference tool, utilize the G
assist with measuring how far the catheter has advanced. The G
provides an approximation that may not be an exact representation of the actual distance
traveled intravascularly and should be confirmed under fluoroscopy (Reference Figure 3).
Introducer
Optional: When used for intravascular length measurement, advance or retract the catheter
between Points A and B utilizing the G
G a Marking System provides an approximation that may not be an exact representation
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of the actual distance traveled intravascularly and should be confirmed under fluoroscopy
(Reference Figure 4).
Introducer
Optional: To facilitate repeat catheter alignment with an additional device with the G
Marking System, ensure the G a
eo
as the initial device.
Note: Ensure the sheath does not move during the withdrawal of the initial device or the
advancement of subsequent devices.
Balloon Reinsertion
Precaution: Do not continue to use the balloon catheter if the shaft has been bent or kinked.
Precaution: For U S .014" guidewire sizes only, prior to re-insertion through the
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introducer sheath, re-activate the hydrophilic coating, and clean the balloon catheter by wiping
the balloon catheter with sterile saline saturated gauze and rinsing with sterile saline. Do not
wipe the balloon catheter with dry gauze.
1. Load the balloon catheter onto a guidewire.
2. Advance the balloon catheter over the pre-positioned guidewire to the introduction site and
through the introducer sheath. If resistance is encountered, replace the previously used
balloon catheter with a new balloon catheter.
3. Continue the procedure according to the "Use of the U
Balloon" section herein.
Warning: After contact with blood or use, this product is a biohazard. Handle and
dispose as a biohazard in accordance with acceptable medical practices and applicable
local, state and federal laws and regulations.
Warranty
Bard Peripheral Vascular warrants to the first purchaser of this product, that this product will
be free from defects in materials and workmanship for a period of one year from the date
of first purchase and liability under this limited product warranty will be limited, to repair or
replacement of the defective product, at Bard Peripheral Vascular's sole discretion, or refunding
your net price paid. Wear and tear from normal use or defects resulting from misuse of this
product is not covered by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT
WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS
OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL
BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL
OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR USE OF THIS
PRODUCT.
Some states/countries do not allow an exclusion of implied warranties, incidental or
consequential damages. You may be entitled to additional remedies under the laws of your
state/country.
An issue or revision date and revision number for these instructions are included for the user's
information on the last page of this booklet. In the event 36 months have elapsed between this
date and product use, the user should contact Bard Peripheral Vascular to see if additional
product information is available.
2
a
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a
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Point A-
Shaft Inserted
49cm
1 1
cm cm
Figure 3
a Marking System to measure the difference. The
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Point B-
Shaft Inserted
44cm
5cm
Distance Between Point A and Point B
Figure 4
markings are at the same location outside the sheath
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S Focused Force PTA
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Marking System to
Marking System
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Point A-
Shaft Inserted
49cm
a
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