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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-15-200
Device Problems Hole In Material (1293); Device Abrasion From Instrument Or Another Object (1387); Material Puncture/Hole (1504); Material Rupture (1546); Material Perforation (2205); Scratched Material (3020)
Patient Problems Intimal Dissection (1333); Vascular Dissection (3160)
Event Date 12/01/2017
Event Type  Injury  
Manufacturer Narrative
The actual device concerned was returned and investigated: a short deep scratch that edge penetrated the balloon was found at 19 mm from the distal tip of the device. Water leaked from the hole when the balloon was pressurized with water. 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. Probable cause(s) and our comment: the balloon should have been injured with a sharp edge of the calcified lesion or another device(s) concomitantly used, and was ruptured when inflated at the rbp. However, the causal relationship between the balloon rupture and the occurrence of vascular dissociation is not clear. No nonconformity or abnormality in the manufacturing processes of the device concerned was found, and accordingly, we determine that the event reported was caused by not any defect of the device.
 
Event Description
The concerned device subject to this reported event, "ikazuchi zero", an rx-type ptca balloon catheter compatible with 0. 014" guidewire (gw), is not distributed in the u. S, 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. This ptca balloon catheter (2. 00 mm x 15 mm), was employed for a ptca of the rca #3. The lesion was calcified chronic total occlusion (cto). Before performing a balloon dilatation, the lesion was crossed by a 0. 014" gw, "sion blue" (asahi intecc, co. ), through 8-fr guiding catheter (gc), "launcher" (medtronic plc) and 8. 2-fr guiding sheath "super sheath" (medikit co. Ltd. ). This balloon catheter was inserted into the lesion and dilated five (5) times. Then, this balloon catheter was replaced with another device (no information about the device was available), and then this device was re-crossed and inflated again at the rbp of 14 atm. Then, the balloon ruptured and a vascular dissection recognized by an angiogram occurred. A stent was placed over the dissociated area for bailout.
 
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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
kazuhiko inoue
2-3-18
nakanoshima, kita-ku
osaka, osaka 530-8-288
JA   530-8288
31814120
MDR Report Key7137240
MDR Text Key95453618
Report Number3002808904-2017-00011
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 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/30/2020
Device Catalogue NumberZE-15-200
Device Lot NumberSP107230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2017
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: 12/21/2017 Patient Sequence Number: 1
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