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

Model Number	H74939171090470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: fge, lit.G4: premarket / 510(k): k141521, k141597.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately calcified brachial vein.A 9.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 8 atmospheres for several seconds, the balloon ruptured around the center of the balloon.The device was removed, and a pinhole was noted.The procedure was completed with another of the same device.No patient complications as a result of this event and the patient condition were good post-procedure.
Additional Manufacturer Narrative
D2b: pro code: fge, lit.G4: premarket / 510(k): k141521, k141597.E1: initial reporter first name: updated.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately calcified brachial vein.A 9.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 8 atmospheres for several seconds, the balloon ruptured around the center of the balloon.The device was removed, and a pinhole was noted.The procedure was completed with another of the same device.No patient complications as a result of this event and the patient condition were good post-procedure.

• 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: 23858292
• Report Number: 2124215-2025-92174
• Device Sequence Number: 12044368
• Product Code: FGE
• UDI-Device Identifier: 08714729793489
• UDI-Public: (01)08714729793489(17)280319(10)36108241
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939171090470
• Device Catalogue Number: H74939171090470
• Device Lot Number: 0036108241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/16/2026
• Date Device Manufactured: 03/20/2025
• 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
• Patient Sex: Unknown