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

Model Number	H74939171100470
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by manufacturer: a visual examination identified that the balloon was not folded, indicating that it had been subjected to positive pressure.The rated burst pressure for this device is 14 atmospheres, as specified in the mustang device specifications.The returned device was received attached to an inflation unit.During testing, positive pressure was applied, and di water leakage was observed from a pinhole in the balloon, located approximately 12 mm proximal to the proximal marker band.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.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review was conducted and confirmed that the event is identified within the product risk documentation and is appropriately documented 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 reported complaint, the most probable cause of this event is adverse event related to the patient condition.The event occurred during the procedure, and there were no reported device interactions, damage, or issues prior to the attempted balloon inflation at a lesion site described as 50% stenosed and mildly tortuous.These findings suggest that the patient anatomy and lesion characteristics most likely contributed to the occurrence of the balloon pinhole leak.
Event or Problem Description
Reportable based on the device analysis completed on 13feb2026.It was reported that the balloon was leaking.The 50% stenosed target lesion was located in the mildly tortuous vessel.A 10.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was inflated to 6 atmospheres, at which point contrast leakage was observed.The procedure was completed using a different device.There were no patient complications reported as a result of this event.However, returned device analysis revealed a balloon pinhole.

• 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: 24582538
• Report Number: 2124215-2026-13944
• Device Sequence Number: 18500503
• Product Code: LIT
• UDI-Device Identifier: 08714729793359
• UDI-Public: (01)08714729793359(17)280924(10)37540864
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Report Date (Section B): 03/12/2026

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: H74939171100470
• Device Catalogue Number: H74939171100470
• Device Lot Number: 0037540864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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: 66 YR
• Patient Sex: Female