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

Model Number	H74939171040440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: fge, lit.G4: premarket / 510(k): k103751, k110122.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres for 30 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.No patient injuries reported, and the patient condition was good post-procedure.
Additional Manufacturer Narrative
D2b: pro code: fge, lit.G4: premarket / 510(k): k103751, k110122.Device evaluated by mfr.: mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 24 atmospheres as per hub.The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from the inner shaft and coming out of the tip.The investigator was unable to inflate the balloon fully due to the leak coming out from the tip.A visual examination found no issue with the markerbands.Visual and tactile examination identified no kinks or damage to the shaft of the returned device.No issues were noted with the tip section of the device.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres for 30 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.No patient injuries reported, and the patient condition was good post-procedure.

• 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: 22733843
• Report Number: 2124215-2025-48889
• Device Sequence Number: 12982861
• Product Code: FGE
• UDI-Device Identifier: 08714729794103
• UDI-Public: (01)08714729794103(17)270122(10)33265135
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103751
• 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): 09/16/2025

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: H74939171040440
• Device Catalogue Number: H74939171040440
• Device Lot Number: 0033265135
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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