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

Model Number	H74939171070370
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst.A mustang balloon was selected for use.The target lesion was located in the superficial femoral artery (sfa).During the procedure, the balloon ruptured.The procedure was completed with this device.There were no patient complications as a result of the event.
Additional Manufacturer Narrative
Device technical analysis: a mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A full circumferential tear was noted approximately 27mm distal from the proximal balloon bond.From the circumferential tear a longitudinal tear was noted.The tear measured approximately 8mm in length, in which this part of the distal section of the balloon was pulled over the distal tip.Both markerbands were undamaged and present on the shaft of the device.No issues noted with the tip section of the device.A visual and tactile examination identified no issues with the shaft of the device.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 that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at the time.Risk review: a risk review performed for mustang confirmed that the event 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.Investigation conclusion: boston scientific concludes the most probable root cause as 'adverse event related to procedure'.
Event or Problem Description
It was reported that the balloon burst.A mustang balloon was selected for use.The target lesion was located in the superficial femoral artery (sfa).During the procedure, the balloon ruptured.The procedure was completed with this device.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: 23959995
• Report Number: 2124215-2026-00335
• Device Sequence Number: 21214350
• Product Code: FGE
• UDI-Device Identifier: 08714729794271
• UDI-Public: (01)08714729794271(17)280729(10)37088016
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/29/2026

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: H74939171070370
• Device Catalogue Number: H74939171070370
• Device Lot Number: 0037088016
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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