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

Model Number	H74939171120470
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon deflated slowly.A mustang balloon was selected for use.During use, it was observed that the balloon deflated slowly.It was immediately removed and exchanged for a new balloon.The procedure was successfully completed.There were no patient complications as a result of the event.
Additional Manufacturer Narrative
Device history record 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 technical analysis: the device was disposed by the healthcare facility.Therefore, a device technical analysis was not performed.Labeling review: there is no evidence the device was used contrary to product labeling per the instructions for use.Risk review a risk review performed for the mustang confirmed that the event of balloon material rupture is a known events defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the complaint information, the investigation conclusion selected was 'cause not established'.
Event or Problem Description
It was reported that the balloon deflated slowly.A mustang balloon was selected for use.During use, it was observed that the balloon deflated slowly.It was immediately removed and exchanged for a new balloon.The procedure was successfully completed.There were no patient complications as a result of the 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22950837
• Report Number: 2124215-2025-61509
• Device Sequence Number: 15586907
• Product Code: FGE
• UDI-Device Identifier: 08714729793441
• UDI-Public: (01)08714729793441(17)260713(10)32012603
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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 Expiration Date: 07/13/2026
• Device Model Number: H74939171120470
• Device Catalogue Number: H74939171120470
• Device Lot Number: 0032012603
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 07/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown