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

Model Number	H74939171080870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
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 device status and 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.An 8.0 x 80, 75 cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured.No additional information was provided.
Event or Problem Description
It was reported that a balloon rupture occurred.An 8.0 x 80, 75 cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured.No additional information was provided.It was further reported that the target lesion, with 100% stenosis, was located in the severely tortuous and severely calcified arteriovenous fistula (avf).During the procedure, the balloon ruptured after 30 seconds of inflation.The procedure was successfully completed using an alternate device.The patients condition was stable and very good post-procedure.
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.

• 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: 23443201
• Report Number: 2124215-2025-78676
• Device Sequence Number: 8533979
• Product Code: FGE
• UDI-Device Identifier: 08714729793656
• UDI-Public: (01)08714729793656(17)280702(10)36888093
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2025

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: H74939171080870
• Device Catalogue Number: H74939171080870
• Device Lot Number: 0036888093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/09/2025
• Date Device Manufactured: 07/03/2025
• 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