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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)
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KANEKA CORPORATION KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) Back to Search Results
Catalog Number ZE-20-200
Device Problems Material Fragmentation (1261); Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/02/2020
Event Type  Injury  
Event Description
When ikazuchi zero was inserted into the severe calcified lesion and was dilated, the balloon was ruptured.A part of the balloon could not be removed from the right coronary artery.The part of the balloon was left in the artery and was tackled to the artery walls with a stent.
 
Event Description
When ikazuchi zero was inserted into the severe calcified lesion and was dilated, the balloon was ruptured.A part of the balloon could not be removed from the right coronary artery.The part of the balloon was left in the artery and was tackled to the artery walls with a stent.
 
Manufacturer Narrative
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 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.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 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.Results of the investigation on returned concerned device: during use, a balloon was damaged by having touched some severe calcified lesion and ruptured at the time of dilation.A part of the balloon and the catheter reached the break by being load of the excessive pulling force in the severe calcified lesion.The length of the residual part inside the patient body was assumed approximately 17mm including distal tip, a radiopaque marker, and balloon.We concluded that the incident is determined not to be caused by any defect of the device.
 
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Brand Name
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
Type of Device
IKAZUCHI ZERO
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
nakanoshima, kita-ku
osaka-city, 530-8 288
JA  530-8288
MDR Report Key10604986
MDR Text Key209141916
Report Number3002808904-2020-00017
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2023
Device Catalogue NumberZE-20-200
Device Lot NumberSR030381
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Date Manufacturer Received09/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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