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

Model Number	H74939171071210
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the av fistula.A 7.0 x 120, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after at 20 atmospheres.The device was removed without any problem, and the procedure was completed with this device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the av fistula.A 7.0 x 120, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after at 20 atmospheres.The device was removed without any problem, and the procedure was completed with this device.There were no patient complications as a result of this event.It was corrected that the balloon burst on the edge of a stent.It was attempted to be withdrawn, but the balloon was stuck.A cut down was performed to release the balloon.
Additional Manufacturer Narrative
B1 - adverse event/product problem: corrected.B2 - outcomes attrib to adv event: corrected.B5 - describe event or problem: corrected.H1 - type of reportable event: corrected.H6 - impact code: corrected.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the mustang device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was failure to follow instructions.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24615070
• Report Number: 2124215-2026-14561
• Device Sequence Number: 13345623
• Product Code: LIT
• UDI-Device Identifier: 08714729794097
• UDI-Public: (01)08714729794097(17)260903(10)32349306
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2026
• Device Model Number: H74939171071210
• Device Catalogue Number: H74939171071210
• Device Lot Number: 0032349306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 09/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown