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Verfügbare Sprachen
6. Dilation Catheter Exchange Procedure
Boston Scientific brand of rapid exchange Monorail catheters have been specifically
designed for rapid, single operator balloon exchanges. To perform a catheter exchange:
a. Open the hemostatic valve.
b. Hold the wire and hemostatic valve in one hand, while grasping the balloon
shaft in the other hand.
c. Maintain the guidewire position in the coronary artery by holding the wire
stationary and begin pulling the dilation catheter out of the guiding catheter
while monitoring the wire position under fluoroscopy.
Table 1. Typical Maverick
Monorail PTCA Dilatation Catheter Compliance
2
Pressure
1.5 mm
atm-kPa
5.0-507
1.48
6.0-608
Nominal
1.50
7.0-709
1.52
8.0-811
1.55
9.0-912
1.57
10.0-1013
1.59
11.0-1115
1.61
12.0-1216
1.63*
13.0-1317
14.0-1419
*Rated Burst Pressure. Do not exceed.
Disposal
To minimize the risk of infection or microbial hazards after use, dispose device and
packaging as follows: After use, device and packaging may contain biohazardous
substances. Any device and packaging that came into contact with biohazardous
substances should be treated and disposed of as biohazardous waste or be treated
and disposed of in accordance with any applicable hospital, administrative, and/or
local government regulations. Use of a biohazardous container with biological hazard
symbol is recommended. Untreated biohazardous waste should not be disposed of in
the municipal waste system.
Post Procedure
Any serious incident associated with this device should be reported to the manufacturer
and relevant local regulatory authority.
INFORMATION TO BRIEF THE PATIENT
The following sections/clauses in the IFU contain information that may be useful for
briefing the patient prior to use of this device:
• Clinical Benefit Statement
• Adverse Events statements with potential relevance to the patient are in italics
Patients should be informed on post-procedure medications.
Black (K) ∆E ≤5.0
Balloon Size
2.0 mm
2.25 mm
2.5 mm
1.97
2.22
2.46
2.00
2.25
2.50
2.03
2.28
2.54
2.06
2.31
2.58
2.09
2.35
2.62
2.12
2.38
2.67
2.15
2.41
2.71
2.19*
2.44
2.75
2.47
2.79
2.51*
2.83*
d. Withdraw the deflated catheter until the opening in the guidewire lumen is
reached. Carefully inch the flexible, distal portion of the balloon dilation catheter
off the guidewire while maintaining guidewire position across the lesion. Close
the hemostatic valve.
e. Slide the distal tip of the catheter out of the hemostatic valve and close the
hemostatic valve onto the wire to hold it securely in place. Completely remove
the balloon from the wire.
f. Prepare the next therapeutic device to be used.
2.75 mm
3.0 mm
3.25 mm
2.71
2.95
3.20
2.75
3.00
3.25
2.79
3.05
3.30
2.83
3.09
3.34
2.87
3.14
3.39
2.91
3.18
3.43
2.95
3.23
3.48
2.99
3.28
3.52
3.03
3.32
3.57
3.07*
3.37*
3.61*
REFERENCES
The physician should consult current practice guidelines and medical literature on
coronary angioplasty, such as those published by ACC, AHA, SCAI, or ESC.
WARRANTY
For device warranty information, visit (www.bostonscientific.com/warranty).
Maverick
2
Monorail and CLIPIT Clip are trademarks of Boston Scientific Corporation or its affiliates.
All other trademarks are the property of their respective owners.
EU Importer: Boston Scientific International B.V., Vestastraat 6, 6468 EX Kerkrade,
The Netherlands
SYMBOL DEFINITIONS
Commonly used medical device symbols that appear on the labeling are defined at
www.bostonscientific.com/SymbolsGlossary.
Additional symbols are defined at the end of this document.
6
3.5 mm
3.75 mm
4.0 mm
3.45
3.70
3.95
3.50
3.75
4.00
3.55
3.80
4.05
3.60
3.85
4.10
3.65
3.90
4.15
3.71
3.95
4.20
3.76
4.00
4.25
3.81*
4.05*
4.31*
MB Drawing 50573139
M
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