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

Model Number	H74939171080670
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b pro code (product code): fge, lit.E1 initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in the mildly tortuous and severely calcified vessel.An 8.0 x 60, 75cm mustang balloon catheter was advanced for left brachiocephalic fistuloplasty procedure.During the procedure, the balloon ruptured upon second inflation at 15 atmospheres for less than 1 minute.The device was removed without any fragments left in the patient, and the procedure was completed with another 8.0 x 60, 75cm mustang balloon.There were no patient complications as a result of this event.

• 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: 21995449
• Report Number: 2124215-2025-28678
• Device Sequence Number: 14530997
• Product Code: FGE
• UDI-Device Identifier: 08714729793885
• UDI-Public: (01)08714729793885(17)271217(10)35504896
• 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
• Report Date (Section B): 05/09/2025

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: H74939171080670
• Device Catalogue Number: H74939171080670
• Device Lot Number: 0035504896
• 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: 04/15/2025
• Initial Report FDA Received Date: 05/09/2025
• Date Device Manufactured: 12/17/2024
• 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 Age: 65 YR
• Patient Sex: Male