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

Model Number	H74939171120670
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit, g4 - premarket / 510(k) #: k141521, k141597.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the arteriovenous fistula.A 12.0 x 60, 75cm mustang was selected for use in a percutaneous transluminal angioplasty.During the procedure, it was noted that the balloon burst while inflating it inside the patient's body.The procedure was completed with another of same device.There were no complications as a result of this event, and the patient was stable post-procedure.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k) #: k141521, k141597.Device evaluated by mfr: the mustang device was returned for evaluation.A visual examination identified that the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied.The balloon was inflated to its rate of burst pressure of 14 atmospheres as per mustang specification with no leaks noted.No issues were identified with balloon inflation or the balloon material.A visual examination of the marker bands identified no issues.A visual and tactile examination identified no issues with the shaft and tip of this device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the arteriovenous fistula.A 12.0 x 60, 75cm mustang was selected for use in a percutaneous transluminal angioplasty.During the procedure, it was noted that the balloon burst while inflating it inside the patient's body.The procedure was completed with another of same device.There were no complications as a result of this event, and the patient was stable post-procedure.

• 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: 23678559
• Report Number: 2124215-2025-87827
• Device Sequence Number: 18354242
• Product Code: FGE
• UDI-Device Identifier: 08714729794738
• UDI-Public: (01)08714729794738(17)280723(10)37045232
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 02/03/2026

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: H74939171120670
• Device Catalogue Number: H74939171120670
• Device Lot Number: 0037045232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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: 71 YR
• Patient Sex: Male