MAUDE Adverse Event Report: KANEKA CORPORATION R2P METACROSS RX; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT

Model Number	BD-P80040ER
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
From the investigation of the actual product, we confirmed a loss of about 42 mm in total for the rupture of the balloon part and the balloon part and the tip part.On the other hand, we have confirmed that there is no problem with the device history record.Our balloon part is designed to rupture in the vertical direction regarding pressure from the inside, but it may rupture in the lateral direction when expanding in calcified lesions or tortuous lesions etc.The actual device was broken by pulling it in a state when the balloon portion was ruptured in the lateral direction.This was considered a malfunction caused by the procedure.
Event or Problem Description
During a fistulogram angioplasty, you could see the balloon not fully expand even at burst pressure.The balloon burst.Upon removal it was noted that the balloon burst circumferentially vs longitudinally and part of the balloon (nylon) was left in the aneurysmal section of the fistula.The balloon catheter was removed and the patient access site closed.

• Brand Name: R2P METACROSS RX
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 10753317
• Report Number: 3002808904-2020-00020
• Device Sequence Number: 16990565
• Product Code: LIT
• UDI-Device Identifier: 04540778166516
• UDI-Public: 04540778166516
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

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: No Information
• Device Expiration Date: 03/31/2023
• Device Model Number: BD-P80040ER
• Device Catalogue Number: BD-P80040ER
• Device Lot Number: SR040143
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2020
• Initial Report FDA Received Date: 10/29/2020
• 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
• Patient Age: 75 YR