MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG?; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74939171120810
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon burst, difficult to remove from the guide, and surgery occurred.The target lesion was located in the arteriovenous fistula.A 12.0 x 80, 135cm mustang balloon catheter was advanced endovascular procedure.During the procedure, the balloon was positioned and inflated, but the balloon burst.Upon removal, it became stuck with the guide.The balloon was not successfully removed, and there were fragments left inside the patient.The procedure was shifted from endovascular to an open surgical procedure to treat the arteriovenous fistula.
Additional Manufacturer Narrative
D2b pro code (product code): fge, lit.G4 premarket / 510(k) k141521, k141597.
Additional Manufacturer Narrative
Device evaluated by mfr: the mustang was returned for analysis.A visual examination of the returned device found that approximately 47mm of the balloon was detached and the remainder of the balloon was noted to be bunched and still on the shaft of the device.The part of the balloon that was detached was noted to have a longitudinal tear and a complete circumferential tear.A visual and tactile examination identified that the shaft was noted to be stretched from the proximal balloon bond distally towards the distal tip causing the markerbands to be loose.
Event or Problem Description
It was reported that balloon burst, difficult to remove from the guide, and open surgery occurred.The target lesion was located in the arteriovenous fistula.A 12.0 x 80, 135cm mustang balloon catheter was advanced endovascular procedure.During the procedure, the balloon was positioned and inflated, but the balloon burst.Upon removal, it became stuck with the guide.The balloon was not successfully removed, and there were fragments left inside the patient.The procedure was shifted from endovascular to an open surgical procedure to treat the arteriovenous fistula.

• Brand Name: MUSTANG?
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21755959
• Report Number: 2124215-2025-19223
• Device Sequence Number: 15503930
• Product Code: LIT
• UDI-Device Identifier: 08714729795285
• UDI-Public: (01)08714729795285(17)270328(10)33717693
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939171120810
• Device Catalogue Number: H74939171120810
• Device Lot Number: 0033717693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female