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 11/26/2019

Event Type  malfunction  

Event Description

It was reported that balloon hole occurred.During preparation of a 4 x 150 x 135 mustang balloon catheter, a hole was noted on the balloon.The procedure was completed with a new mustang balloon catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.:the device was returned for analysis.A circumferential tear was identified within the distal markerband section of the balloon.A red blood like substance was observed in the balloon.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.The rated burst pressure as per the print on the hub is 24 atmospheres.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

It was reported that that balloon hole occurred.During preparation of a 4 x 150 x 135 mustang balloon catheter, a hole was noted on the balloon.The procedure was completed with a new mustang balloon catheter.No patient complications were reported.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9477798
• MDR Text Key: 176483570
• Report Number: 2134265-2019-15789
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729793694
• UDI-Public: 08714729793694
• Combination Product (y/n): N
• PMA/PMN Number: K103751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0024388408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1