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

Model Number	H74939171050470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the cephalic vein.A 5.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon rupture during the second inflation at 12 atm.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the cephalic vein.A 5.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon rupture during the second inflation at 12 atm.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that 99% is the stenosed target lesion.
Additional Manufacturer Narrative
Device analysis: a visual examination found a complete circumferential tear in the balloon material confirming the rupture.No issues were noted with the shaft, markerbands or tip of the device.No other issues were identified during the product analysis.The ifu states: if resistance is felt during withdrawal of the dilatation catheter, it is recommended to extract the entire system with the introducer/guide sheath.Risk review: a risk review was completed and confirmed that the event of balloon - material rupture was defined in the risk documentation and is documented accordingly.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion: based on the complaint review and product analysis, the most probable cause of the event was related to patient condition and lesion characteristics.No device damage or issue was reported prior to the second inflation at the lesion site.The balloon rupture likely compromised balloon refolding, resulting in resistance during withdrawal through the guide/sheath.The circumferential tear most likely occurred due to excessive tensile force applied during device removal.

• 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: 24065944
• Report Number: 2124215-2026-02249
• Device Sequence Number: 9113637
• Product Code: LIT
• UDI-Device Identifier: 08714729793366
• UDI-Public: (01)08714729793366(17)280306(10)36010664
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: H74939171050470
• Device Catalogue Number: H74939171050470
• Device Lot Number: 0036010664
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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
• Patient Sex: Unknown