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	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit g4: premarket / 510(k): k141521, k141597.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 9.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the second inflation at 8 atmospheres for 3 seconds, the balloon ruptured in a pinhole form.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.D2b: pro code: (product code): fge, lit.G4: premarket / 510(k): k141521, k141597.
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 9.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the second inflation at 8 atmospheres for 3 seconds, the balloon ruptured in a pinhole form.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the patient presented with severe calcification, which was the only anatomical challenge identified.This severe calcification was considered the primary contributing factor to the adverse event.After further evaluation, it was determined that procedural factors did not contribute to the event, and the cause was attributed to the patient's underlying condition.

• 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: 23860289
• Report Number: 2124215-2025-92188
• Device Sequence Number: 9464779
• Product Code: FGE
• UDI-Device Identifier: 08714729793489
• UDI-Public: (01)08714729793489(17)280619(10)36798529
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 0036798529
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 12/30/2025
• Date Device Manufactured: 06/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: RADIFOCUS; GUIDEWIRE: RADIFOCUS; INFLATION DEVICE: NIPRO; INFLATION DEVICE: NIPRO; INTRODUCER SHEATH: DESTINATION 6FR; INTRODUCER SHEATH: DESTINATION 6FR; MICRO CATHETER: ARMET 18; MICRO CATHETER: ARMET 18
• Patient Sex: Unknown