MAUDE Adverse Event Report: KANEKA CORPORATION R2P METACROSS RX PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL,,

Catalog Number	BD-P50200ER
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2019
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 for every product, and the finished product inspections 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 speculate the reported situation as follows: because it is used in calcified lesions, the rupture occurred because the balloon was damaged at the hard part of the lesion.Further, the operation was not possible at the lesioned part or the tip of the combined device (for example, gc), and when the catheter was removed from the stucked state, the balloon was broken by an excessive tensile force.This was considered a malfunction caused by the procedure.
Event or Problem Description
The account was attempting to pta a heavily calcified sfa when the balloon would not advance forward or could it be removed over the wire before it fractured.An open surgical foreign body retrieval was performed to remove the balloon.The balloon was removed.The patient is stable and recovering.

• Brand Name: R2P METACROSS RX PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL,,
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima,kita-ku; osaka, osaka 53082 88; JA 5308288
• MDR Report Key: 9231315
• Report Number: 3002808904-2019-00029
• Device Sequence Number: 387991
• Product Code: LIT
• UDI-Device Identifier: 04540778167117
• UDI-Public: 04540778167117
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 03/31/2022
• Device Catalogue Number: BD-P50200ER
• Device Lot Number: SP049083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/24/2019
• 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: Required Intervention
• Patient Age: 62 YR