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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS,

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KANEKA CORPORATION KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, Back to Search Results
Catalog Number ZE-6-100P
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2019
Event Type  Injury  
Manufacturer Narrative
The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections including the visual test, shaft pressurized test and the balloon-wrapping test for every product, and the finished product inspections including the shaft tensile strength test and the repetitive balloon inflation/deflation test on representative samples based on sampling plan. No nonconformity or abnormality in the manufacturing processes of the device concerned was found. The actual device concerned was returned and investigated: the balloon had a trace that seemed torn and cracked in the circumferential direction (lateral crack) at a position 3. 5 mm from the rear end of the balloon straight tube. The inner shaft was broken at a portion of 20 mm from the balloon break to the hand side. The radiopaque marker was not returned. The outer shaft showed no evidence of extensive stretching. The length of the broken piece was estimated to be about 30 mm from the tip to the broken part of the inner shaft. (the tip, balloon (approx. 7 mm), inner shaft, and radiopaque marker are likely to remain intact). Probable cause(s) and our comment: we speculated the reported situation as follows: as a result of repeated dilatation for highly calcified lesions with high meandering, it is assumed that the balloon broke laterally and the inner broke when the catheter was withdrawn.
 
Event Description
The concerned device subject to this reported event, "ikazuchi zero", an rx-type ptca balloon catheter compatible with 0. 014" guide wire (gw), is not distributed in the us, however, we intend to report this case as the event occurred on one of the similar devices for "rx takeru ptca balloon dilatation catheter" distributed in the us under 510(k) # k163372. Balloon rupture occurred during treatment of lad # 9 cto lesion with this product. The tip of the tip is trapped when the catheter is removed, and the tip of the balloon is broken. The procedure ends without being collected.
 
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Brand NameKANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS,
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
nakanoshima, kita-ku
osaka, osaka 530-8 288
JA 530-8288
Manufacturer Contact
yoshiyuki kitamura
2-3-18
nakanoshima,kita-ku
osaka, osaka 530-8-288
JA   530-8288
MDR Report Key9096487
MDR Text Key162436963
Report Number3002808904-2019-00027
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2022
Device Catalogue NumberZE-6-100P
Device Lot NumberSP029368
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2019 Patient Sequence Number: 1
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