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

Model Number	H74939171090840
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device detachment occurred.A 9.0 x 80, 40cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon catheter fractured during inflation, and it was retrieved using with kelly clamps and resulting in a prolonged procedure.The procedure was completed using with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
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.Device evaluation by manufacturer: a mustang device batch # 34390742, 18 atm was received for analysis.The device was received in two sections.A visual and tactile examination found the shaft of the device to be detached 115mm proximal from the distal tip.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon section was detached from the shaft, which confirms the event.The rated burst pressure for this device as per mustang specification is 18 atmospheres.A visual examination observed no damage to the tip of the device.No issues noted with the markerbands.Labeling review: review of the complaint information and the instructions for use did not reveal any evidence of device off-label use or failure to follow instructions.Investigation conclusion: boston scientific concludes the most probable root cause as 'adverse event related to procedure', based on both the results of product analysis, and there being no reported device interaction/ damage or issue until inflation was attempted.This would suggest that procedural factors such as patient anatomy/lesion characteristics most probably contributed to the shaft detachment, as it is most likely that the user applied excessive force to the device when advancing it, and kinked it in the process, causing a weak point in the shaft and subsequently detaching.Risk review: a risk review performed for the mustang? device confirmed that the event of detachment of device or device component is a known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.
Event or Problem Description
It was reported that device detachment occurred.A 9.0 x 80, 40cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon catheter fractured during inflation, and it was retrieved using with kelly clamps and resulting in a prolonged procedure.The procedure was completed using with a different device.There were no patient complications as a result of this event.

• 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: 24146705
• Report Number: 2124215-2026-04044
• Device Sequence Number: 15755828
• Product Code: LIT
• UDI-Device Identifier: 08714729795216
• UDI-Public: (01)08714729795216(17)270709(10)34390742
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• 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: H74939171090840
• Device Catalogue Number: H74939171090840
• Device Lot Number: 0034390742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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