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

Model Number	H74939171070670
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a moderately tortuous and moderately calcified vessel.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilation in a fistuloplasty procedure.During the procedure, the balloon ruptured at rated pressure.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1- initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a moderately tortuous and moderately calcified vessel.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilation in a fistuloplasty procedure.During the procedure, the balloon ruptured at rated pressure.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the balloon ruptured upon second inflation at 10 atmospheres for one minute.

• 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: 22197379
• Report Number: 2124215-2025-38309
• Device Sequence Number: 9275083
• Product Code: FGE
• UDI-Device Identifier: 08714729793861
• UDI-Public: (01)08714729793861(17)271113(10)35270841
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 07/31/2025

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: H74939171070670
• Device Catalogue Number: H74939171070670
• Device Lot Number: 0035270841
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/31/2025
• Date Device Manufactured: 11/13/2024
• 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