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resistance is ignored and excessive force is applied, it may
lead to damage of the vessels or to the catheter shaft
breaking and remaining inside the body).
15. During usage, the catheter shaft should be replaced for
any bend, break or kink. (If the catheter continues to be
used and such occurrence is ignored, the catheter shaft
may be damaged and remain inside body).
16. If a great resistance is encountered during insertion,
movement, or pulling out of this catheter, it should be
verified that the guidewire is not tangled. If so, the tangling
of the guidewire should be removed. (Since the guidewire
lumen of this catheter is short, the guidewire may wind
around the catheter shaft. In addition, while drawing this
catheter back into the guiding catheter inside vessels, the
wide-angle separation between the catheter shaft and
guidewire may occur. Under this circumstance, a forced
withdrawal may lead to damage to the guidewire or
catheter.)
17. A catheter with any sign indicating damage should not be
used.
18. Due to the lack of conductivity of twist forces, the catheter
shaft should not be twisted (If twisted, the catheter shaft
may be damaged and then remain inside the body).
19. Challenging lesions such as calcified or tortuous lesions
may not be crossed with this catheter. The physician in
charge of the procedure should determine whether this
catheter is applicable based on his/her past experiences.
20. Precautions should be taken to prevent any damage to the
catheter by the surgical knife or scissors.
21. During the usage of this catheter, the temperature, blood
pressure, pulse, and respiration of patients should be
monitored. In case of any abnormality, the procedure
should be stopped or appropriate measures taken based
on the physician's judgment.
22. After use, dispose of product and packaging in accordance
with hospital, administrative and/or relevant national
regulations.
23. If any abnormalities are detected during inflation of the
balloon, apply negative pressure immediately and interrupt
the operation.
24. Do not immerse the catheter in hot water or chemicals
such as disinfectants [This may adversely affect its
function.]
[Adverse events]
Adverse events related to the product include, but are not
limited to, infarction caused by occlusion of distal vessels or
side branch, vasospasm, stripping of vascular endothelium,
dissection of vascular intima, re-occlusion, vascular perforation
or rupture, unstable angina, blood pressure fluctuation, stroke,
shock, reaction to drugs, reaction to contrast media, renal
insufficiency, transient ischemia, air embolism,
thromboembolism, internal bleeding, hematoma, infection, etc.
These adverse events may cause emergent coronary bypass
surgery, myocardial infarction, re-stenosis, cardiac tamponade,
hemorrhage, emergent brain surgery for cerebral infarction,
formation of vessel fistula, aneurysm, arrhythmia, and even
death.
[Storage, care and expiration date]
1. Store in a cool, dark, and dry place between 5̊ C and 30̊ C
(41̊ F and 86̊ F ) avoiding exposure to water and direct
sunlight, extreme temperature, or high humidity.
2. The expiration date is indicated on the box. Do not use after
the expiration date.
[Package]
1 set (one primary packaging) / box
Contents)
1) Balloon catheter x 1
2) Flushing tool x 1
3) Catheter clip x 1
[Names and Addresses of Manufacturer,
Manufacturing Site and EC Representative]
［Manufacturer］
Name:
KANEKA CORPORATION
Address: 3-18, 2-Chome, Nakanoshima, Kita-ku, Osaka-city,
OSAKA, 530-8288 JAPAN
Tel. No.: (+81)-(0) 6-6226-5256
Fax No.: (+81)-(0) 6-6226-5143
［Manufacturing Site］
Name:
KANEKA CORPORATION OSAKA PLANT
Address:
5-1-1, Torikai-Nishi, Settsu-city, OSAKA,
566-0072 JAPAN
［EC Representative］
Name:
KANEKA PHARMA EUROPE N.V.
Address:
Nijverheidsstraat 16, 2260 Westerlo-Oevel,
Belgium
Tel. No.:
(+32)-(0) 14-256-297
Fax No.:
(+32)-(0) 14-256-298
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