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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KANEKA CORPORATION RX NC TAKERU PTCA BALLOON DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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KANEKA CORPORATION RX NC TAKERU PTCA BALLOON DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Device Problem Inflation Problem (1310)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Type  Injury  
Manufacturer Narrative
Investigation result. Since the actual device was not returned, so it could not be investigated. Since the lot number and the serial number were not known, the device history records(dhr) could not be confirmed. Probable cause and our comment. Although the details of the used balloon size, stent size and procedure information, etc. Are unknown, this adverse event is considered to be the cause of the procedure due to overpressurization of the balloon.
 
Event Description
Ic was performing a post stent dilation with a takeru nc size unavailable at this time and the balloon was inflated to beyond the sizing markers and outside the stent. Ic determined that balloon caused vessel trauma to the surrounding area outside stent. Physician was dr. (b)(6).
 
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Brand NameRX NC TAKERU PTCA BALLOON DILATATION CATHETER
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 Key8872429
MDR Text Key153688930
Report Number3002808904-2019-00020
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170941
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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
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: 08/07/2019 Patient Sequence Number: 1
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