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

Model Number	H74939171080470
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	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified arteriovenous (av) shunt.An 8.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.No challenging anatomy was reported.During the first inflation, the balloon ruptured before inflation reached the device rated burst pressure (rbp).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
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 100% stenosed target lesion was located in the moderately tortuous and mildly calcified arteriovenous (av) shunt.An 8.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.No challenging anatomy was reported.During the first inflation, the balloon ruptured before inflation reached the device rated burst pressure (rbp).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
D2b: pro code: (product code): fge, lit g4: premarket / 510(k): k141521, k141597.A mustang device was returned for analysis.A visual examination revealed that the balloon was not folded, indicating that it had been subjected to positive pressure.A longitudinal tear was identified in the balloon material, measuring approximately 33mm in length.The tear extended from a point 14mm proximal to the proximal markerband to 6mm distal to the distal markerband.No damage was observed on the tip of the device.Additionally, a visual and tactile inspection revealed a shaft kink approximately 20mm distal to the distal end of the strain relief.Both markerbands were intact and undamaged on the shaft of the 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: 23578624
• Report Number: 2124215-2025-83957
• Device Sequence Number: 18447226
• Product Code: FGE
• UDI-Device Identifier: 08714729793328
• UDI-Public: (01)08714729793328(17)280528(10)36629847
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/24/2025

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: H74939171080470
• Device Catalogue Number: H74939171080470
• Device Lot Number: 0036629847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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