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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
Catalog Number DC-RZ3015UA2
Device Problems Material Separation (1562); Use of Device Problem (1670)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 01/23/2019
Event Type  Injury  
Manufacturer Narrative
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: we speculated the reported situation as follows: the balloon should have been caught at the lesion (cto with a high calcium lesion) and became unable to pull back further. With further attempt to forcibly pull back the device resulted in breakage of the shaft including the balloon. 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 but the device handling-issues.
 
Event Description
Cto case was being performed with a high calcium lesion. The physician was able to get radial access and used a guide catheter (7fr, ebu 3. 75) into the lca and advanced a guidewire (asahi fielder xt, asahi intecc) and a trapliner (teleflex) down the circ. The physician advanced the rx nc takeru over the guidewire to the calcified lesion. The rx nc takeru was inflated to 20 atm and burst due to the calcium. The rx nc takeru was wedged into the calcium valve and when the physician pulled back to remove the balloon, the balloon split and partial of it was left behind. The physician then was able to pass a rotablator (boston scientific) 1. 5 burr pass the lesion and broke up the balloon piece that was left behind. He did not try to remove the pieces and left it in the patient and has no concern with it. He stated that the pieces are subintimal and is not concerned to have the pieces there.
 
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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, osaka 530-8 288
JA 530-8288
Manufacturer Contact
yoshiyuki kitamura
2-3-18
nakanoshima, kita-ku
osaka, osaka 530-8-288
JA   530-8288
MDR Report Key8352648
MDR Text Key136601984
Report Number3002808904-2019-00004
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 foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Catalogue NumberDC-RZ3015UA2
Device Lot NumberSP028296
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/12/2018
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: 02/19/2019 Patient Sequence Number: 1
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