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

Model Number	H74939171060440
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	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the artificial arteriovenous fistula.A 6.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was longitudinally ruptured after the first inflation at 22 atmospheres for 40 seconds.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the artificial arteriovenous fistula.A 6.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was longitudinally ruptured after the first inflation at 22 atmospheres for 40 seconds.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that 85% stenosed target lesion was located in the moderately tortuous and mildly calcified left upper extremity.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection showed that the balloon was not in a folded state, indicating exposure to positive pressure.A circumferential balloon tear was identified approximately 30 mm distal to the proximal balloon bond, with an associated longitudinal extension of the tear.The distal portion of the balloon material had been displaced distally toward the device tip.No damage was observed on the tip itself.Further visual and tactile examination revealed shaft damage located approximately 5 mm distal to the distal markerband.Additionally, the distal markerband was found to be damaged.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the artificial arteriovenous fistula.A 6.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was longitudinally ruptured after the first inflation at 22 atmospheres for 40 seconds.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that 85% stenosed target lesion was located in the moderately tortuous and mildly calcified left upper extremity.

• 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: 22902089
• Report Number: 2124215-2025-59921
• Device Sequence Number: 15458343
• Product Code: LIT
• UDI-Device Identifier: 08714729793564
• UDI-Public: (01)08714729793564(17)270813(10)34625987
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 11/21/2025

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: H74939171060440
• Device Catalogue Number: H74939171060440
• Device Lot Number: 0034625987
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 10/28/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/22/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 60 KG