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

Model Number	H74939171070670
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 60, 75cm mustang was advance for dilation.It was noted that the balloon was ruptured.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 60, 75cm mustang was advance for dilation.It was noted that the balloon was ruptured.There were no patient complications as a result of this event.It was further reported that the 100% stenosed target lesion was located in the severely tortuous and severely calcified arteriovenous fistula (avf).The balloon ruptured upon second inflation for 1 minute.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 60, 75cm mustang was advance for dilation.It was noted that the balloon was ruptured.There were no patient complications as a result of this event.It was further reported that the 100% stenosed target lesion was located in the severely tortuous and severely calcified arteriovenous fistula (avf).The balloon ruptured upon second inflation for 1 minute.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.Investigation results: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 42mm in length and extended from a position 6mm distal of the proximal markerband to 11mm proximal of the distal markerband, which confirms the event.Device history record (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 was completed and confirmed that the event of balloon- material rupture was defined in the risk documentation and is documented accordingly in the prr.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, boston scientific has assigned an investigation conclusion code of "adverse event related to patient condition".

• 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: 24079745
• Report Number: 2124215-2026-02728
• Device Sequence Number: 12216372
• Product Code: FGE
• UDI-Device Identifier: 08714729793861
• UDI-Public: (01)08714729793861(17)280820(10)37260399
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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: H74939171070670
• Device Catalogue Number: H74939171070670
• Device Lot Number: 0037260399
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 03/05/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/12/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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