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

Model Number	H74939171071070
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
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 to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 80mm in length and extended from a position 15mm distal of the proximal markerband to 8mm proximal of the distal markerband.It is not possible to inflate the balloon with a tear in the balloon material and shaft of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 30oct2025.It was reported that balloon failed to expand well in the lesion.The 70 % stenosed target lesion was located in the severely tortuous and moderately calcified arteriovenous graft.A 7.0 x 100, 75cm mustang was selected for percutaneous transluminal angioplasty.However, during second inflation at 20 atmospheres for 1 minute, the balloon failed to expand well.The procedure was completed with a different device.There were no patient complications as a result of this event.However, device analysis revealed a longitudinal tear in the balloon material.
Additional Manufacturer Narrative
Device evaluated by mfr: the mustang device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 80mm in length and extended from a position 15mm distal of the proximal markerband to 8mm proximal of the distal markerband.It is not possible to inflate the balloon with a tear in the balloon material and shaft of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 30oct2025.It was reported that balloon failed to expand well in the lesion.The 70 % stenosed target lesion was located in the severely tortuous and moderately calcified arteriovenous graft.A 7.0 x 100, 75cm mustang was selected for percutaneous transluminal angioplasty.However, during second inflation at 20 atmospheres for 1 minute, the balloon failed to expand well.The procedure was completed with a different device.There were no patient complications as a result of this event.However, device analysis revealed a longitudinal tear in the balloon material.

• 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: 23632701
• Report Number: 2124215-2025-85832
• Device Sequence Number: 13090603
• Product Code: FGE
• UDI-Device Identifier: 08714729793779
• UDI-Public: (01)08714729793779(17)280512(10)36502494
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: H74939171071070
• Device Catalogue Number: H74939171071070
• Device Lot Number: 0036502494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 02/08/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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: 67 YR
• Patient Sex: Male