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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION IKAZUCHI ZERO CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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KANEKA CORPORATION IKAZUCHI ZERO CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number ZE-20-300
Device Problem Insufficient Information (3190)
Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)
Event Date 08/02/2019
Event Type  Injury  
Manufacturer Narrative
Since the actual device was not retuned, we investigated the device history records. 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: adverse event was caused by dilation in the highly calcified lesion.
 
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 no 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. Complex angioplasty. Highly calcified lesion. When the balloon was inflated in the lad for predilation at 14 atm during 4 seconds, the artery was perforated, causing also a tamponade and cardiac arrest. The patient was saved using brief external cardiac massage, adrenaline, intubation and mechanical ventilation. Drainage of pericardial effusion (480cc). Pci was finished with a covered stent and 2 des in the lad. The pericardial effusion disappeared after drainage. Patient stabilized and should come out of the hospital soon.
 
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Brand NameIKAZUCHI ZERO
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
nakanoshima,kita-ku
osaka-city, osaka 530-8 288
JA 530-8288
Manufacturer Contact
yoshiyuki kitamura
2-3-18
nakanoshima,kita-ku
osaka-city, osaka 530-8-288
JA   530-8288
MDR Report Key8913820
MDR Text Key157738109
Report Number3002808904-2019-00023
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeFR
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 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberZE-20-300
Device Lot NumberSP059264
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2019
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: 08/20/2019 Patient Sequence Number: 1
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