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

Model Number	H74939171060670
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 6.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon burst.No additional information was reported.
Additional Manufacturer Narrative
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.A 6.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon burst.No additional information was reported.It was further reported that the 100% stenosed target lesion was located in the severely tortuous and severely calcified arteriovenous fistula.The patients anatomy was considered challenging.It was also reported that the balloon remained ruptured for approximately 30 minutes.The procedure was completed with a non-boston scientific device.
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.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.G4: premarket / 510(k): k141521, k141597.The mustang device was returned for analysis.A visual examination identified that the balloon had been subjected to positive pressure.A pinhole in the balloon material was identified confirming the event.No damage or issues were found with the tip or markerbands of the device.Shaft kinks were also noted.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a balloon rupture occurred.A 6.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon burst.No additional information was reported.It was further reported that the 100% stenosed target lesion was located in the severely tortuous and severely calcified arteriovenous fistula.The patient's anatomy was considered challenging.It was also reported that the balloon remained ruptured for approximately 30 minutes.The procedure was completed with a non-boston scientific device.

• 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: 23678054
• Report Number: 2124215-2025-87810
• Device Sequence Number: 16021172
• Product Code: FGE
• UDI-Device Identifier: 08714729793762
• UDI-Public: (01)08714729793762(17)280812(10)37196180
• 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,Followup
• Report Date (Section B): 02/15/2026

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: H74939171060670
• Device Catalogue Number: H74939171060670
• Device Lot Number: 0037196180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 01/27/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/23/2025; 02/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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