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

Model Number	H74939171071070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
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 moderately calcified vein.A 7.0 x 100, 75cm mustang balloon catheter was advanced for dilation.During the first inflation at 6 atmospheres for 10 seconds, the balloon ruptured in a pinhole form.The device was removed using normal method without issue and the procedure was completed with another of same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vein.A 7.0 x 100, 75cm mustang balloon catheter was advanced for dilation.During the first inflation at 6 atmospheres for 10 seconds, the balloon ruptured in a pinhole form.The device was removed using normal method without issue and the procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that the patient's anatomy was not considered challenging, and no patient-related factors contributed to the event.Additionally, no procedural factors were identified as contributing to the occurrence.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.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: 23506890
• Report Number: 2124215-2025-81131
• Device Sequence Number: 9140791
• Product Code: FGE
• UDI-Device Identifier: 08714729793779
• UDI-Public: (01)08714729793779(17)270730(10)34533356
• 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): 11/19/2025

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: H74939171071070
• Device Catalogue Number: H74939171071070
• Device Lot Number: 0034533356
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/09/2025
• Supplement Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 07/30/2024
• 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