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

Model Number	H74939171060440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: fge, lit.G4: premarket / 510(k): k141521, k141597.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left forearm shunt.A 6.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 14 atmospheres for 10 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.No patient adverse event was reported, and the patient condition was good post-procedure.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed that the balloon was not folded, indicating exposure to positive pressure.A longitudinal tear was observed in the balloon material, measuring approximately 18 mm in length.The tear extended from approximately 3 mm proximal to the proximal marker band to approximately 13 mm distal to the proximal marker band.Examination of the device tip showed no evidence of damage.Visual and tactile inspection of the shaft identified no kinks, deformation, or damage.Both marker bands were intact, undamaged, and securely present on the shaft.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left forearm shunt.A 6.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.However, during first inflation at 14 atmospheres for 10 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.No patient adverse event was reported, and the patient condition was good 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: 23824062
• Report Number: 2124215-2025-91283
• Device Sequence Number: 9386964
• Product Code: LIT
• UDI-Device Identifier: 08714729793564
• UDI-Public: (01)08714729793564(17)280107(10)35568327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141597
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: H74939171060440
• Device Catalogue Number: H74939171060440
• Device Lot Number: 0035568327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE USED: RADIFOCUS.; GUIDEWIRE USED: RADIFOCUS.; INFLATION DEVICE USED: GM30.; INFLATION DEVICE USED: GM30.; INTRODUCER SHEATH USED: NIPRO.; INTRODUCER SHEATH USED: NIPRO.
• Patient Sex: Unknown