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

Model Number	H74939171070470
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.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 38 mm in length.The tear extended from approximately 7 mm distal to the proximal marker band to approximately 5 mm distal to the distal marker band.Due to the presence of the longitudinal tear, inflation testing could not be performed.Visual examination showed no evidence of damage to the device tip.Visual and tactile inspection of the shaft revealed no kinks or damage.Both marker bands were present and intact on the shaft.This concludes the product analysis.
Event or Problem Description
Reportable based on the device analysis completed on 5jan2026.It was reported that balloon failure to inflate occurred.A 7.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon continuous contrast medium leakage was observed and the balloon failed to expand.The procedure was completed using with another of the same device.There were no patient complications reported as a result of this event.However, complete device analysis revealed, a longitudinal tear.

• 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: 24254036
• Report Number: 2124215-2026-06121
• Device Sequence Number: 15531030
• Product Code: LIT
• UDI-Device Identifier: 08714729793342
• UDI-Public: (01)08714729793342(17)280619(10)36798381
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Type of Report: Initial
• 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: H74939171070470
• Device Catalogue Number: H74939171070470
• Device Lot Number: 0036798381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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: 65 YR
• Patient Sex: Male