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

Model Number	H74939171050440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel in the left forearm.A 5.0 x 40, 40cm mustang balloon catheter was advance for dilation.During the procedure, the balloon ruptured upon third inflation at 24 atmospheres for 1 minute.The device was removed without any problem, and the procedure was completed with another of the same device.There was no patient complications noted as a result of this event, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
A2 - age at time of event: under 18 years old.D2b - pro code (product code): fge, lit.E1 - initial reporter city: (b)(6).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: 22061905
• Report Number: 2124215-2025-32649
• Device Sequence Number: 7812097
• Product Code: FGE
• UDI-Device Identifier: 08714729793731
• UDI-Public: (01)08714729793731(17)271231(10)35537949
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: H74939171050440
• Device Catalogue Number: H74939171050440
• Device Lot Number: 0035537949
• 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: 05/15/2025
• Initial Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 12/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - RADIFOCUS; INFLATION DEVICE - GM30; INTRODUCER SHEATH - ULTRA HIGH FLOW
• Patient Sex: Unknown