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

Model Number	H74939171120470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the severely calcified vessel common iliac artery.A 12.0 x 40, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon second inflation at 6 atmospheres (atm).The device was removed without any problem, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the severely calcified vessel common iliac artery.A 12.0 x 40, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon second inflation at 6 atmospheres (atm).The device was removed without any problem, and the procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported the balloon ruptured at 5 seconds.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.B5: describe event or problem: updated.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24670512
• Report Number: 2124215-2026-15908
• Device Sequence Number: 20094306
• Product Code: FGE
• UDI-Device Identifier: 08714729793441
• UDI-Public: (01)08714729793441(17)271122(10)35342425
• 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): 04/08/2026

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: H74939171120470
• Device Catalogue Number: H74939171120470
• Device Lot Number: 0035342425
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 11/22/2024
• 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
• Patient Sex: Unknown