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

Model Number	H74939171070470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured occurred.The patient had stenosis of the artificial arteriovenous fistula and was taken to the operating room for a fistula balloon angioplasty.A 7.0 x 40, 75cm mustang was advanced for dilation.During the procedure, it was noted that the balloon was ruptured.The procedure was successfully completed using the third replacement balloon, which resulted in an extended procedure time.Postoperative inspection of the balloon wall revealed a visible tear, but no significant fragmentation was observed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.E1: (b)(6).Media evaluation by manufacturer: the device was not returned.However, a media was provided with the report which consisted of a short video.The video appears to show the mustang balloon device after being taken out of the patient, and it is leaking while being flushed.The event can be confirmed from this media.
Event or Problem Description
It was reported that balloon ruptured occurred.The patient had stenosis of the artificial arteriovenous fistula and was taken to the operating room for a fistula balloon angioplasty.A 7.0 x 40, 75cm mustang was advanced for dilation.During the procedure, it was noted that the balloon was ruptured.The procedure was successfully completed using the third replacement balloon, which resulted in an extended procedure time.Postoperative inspection of the balloon wall revealed a visible tear, but no significant fragmentation was observed.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: 24020364
• Report Number: 2124215-2026-01521
• Device Sequence Number: 9183393
• Product Code: FGE
• UDI-Device Identifier: 08714729793342
• UDI-Public: (01)08714729793342(17)271008(10)35015977
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: H74939171070470
• Device Catalogue Number: H74939171070470
• Device Lot Number: 0035015977
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 10/08/2024
• 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: 59 YR
• Patient Sex: Male