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

Catalog Number	BD-P60040ER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product lot information was not available and the actual product could not be investigated, it was not possible to identify the occurrence of balloon rupture as the cause of the inability to pull back into the sheath.A rupture occurs when the balloon is expanded after a preparation operation such as priming is performed from the procedure information and the catheter reaches the target lesion site.Therefore, it is inferred that the rupture occurred because the balloon was damaged at the hard part of the lesion.This was considered a malfunction caused by the procedure.
Event or Problem Description
This product was used for peripheral vascular treatment with trans-radial intervention approach.During the procedure, a balloon popped in the iliac vessel.As a result, the balloon could not be pulled back into the sheath.The hcp had to make an incision in the patients wrist in order to get the balloon out of the radial access site.

• 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: 9415003
• Report Number: 3002808904-2019-00031
• Device Sequence Number: 16789025
• Product Code: LIT
• UDI-Device Identifier: 04540778166479
• UDI-Public: 04540778166479
• 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): 11/06/2019

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 Catalogue Number: BD-P60040ER
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2019
• Initial Report FDA Received Date: 12/05/2019
• 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