MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG CATHETER, BILIARY, DIAGNOSTIC

Model Number 24672

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified right superior femoral artery. After crossing a v18 guide wire, a 7. 0 x 150, 75cm mustang catheter was advanced for pre-dilatation. However, during inflation at nominal pressure, the balloon ruptured. The device was replaced with another mustang balloon and the procedure was completed with a non-bsc stent. There were no patient complications reported.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9534750
• MDR Text Key: 177152312
• Report Number: 2134265-2019-16293
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729794578
• UDI-Public: 08714729794578
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/01/2021
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0022460774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial