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

Catalog Number	DC-RZ3015UA2
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: RX NC TAKERU PTCA BALLOON DILATATION CATHETER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8 288; JA 530-8288
• MDR Report Key: 8352648
• Report Number: 3002808904-2019-00004
• Device Sequence Number: 2253990
• Product Code: LOX
• UDI-Device Identifier: 04540778170513
• UDI-Public: 04540778170513
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: DC-RZ3015UA2
• Device Lot Number: SP028296
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability