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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.
 
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Brand NameKANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
Type of DeviceIKAZUCHI ZERO
Manufacturer (Section D)
KANEKA CORPORATION
2-3-18
nakanoshima, kita-ku
osaka-city, 530-8 288
JA 530-8288
Manufacturer (Section G)
KANEKA CORPORATION OSAKA PLANT
5-1-1
torikai-nishi
settsu-city, osaka 566-0 072
JA 566-0072
Manufacturer Contact
joji sengoku
1-12-32
akasaka
minato-ku, tokyo 107-6-028
JA   107-6028
MDR Report Key10604986
MDR Text Key209141916
Report Number3002808904-2020-00017
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
Reporter Occupation Pharmacist
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
Device Catalogue NumberZE-20-200
Device Lot NumberSR030381
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2020
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: 09/30/2020 Patient Sequence Number: 1
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