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

Model Number BD-P80040ER

Device Problems Material Rupture (1546); Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/02/2020

Event Type  Injury  

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 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
• Type of Device: 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
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu-city, osaka 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 10700-52 ; JA 1070052
• MDR Report Key: 10753317
• MDR Text Key: 213670636
• Report Number: 3002808904-2020-00020
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: BD-P80040ER
• Device Catalogue Number: BD-P80040ER
• Device Lot Number: SR040143
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2020
• 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: 10/29/2020 Patient Sequence Number: 1