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

Model Number	H74939171060670
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1; initial reported address 1 and city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the radial cephalic vein.A 6.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after being inflated twice at 24 atmospheres, and the wire also became detached.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.
Additional Manufacturer Narrative
(b)(6).The device was returned for analysis.A visual and tactile examination identified that the shaft was stretched on different locations along the length of the device.The shaft was noted to be kinked, located when the shaft was stretched.A visual examination of the returned device found that the balloon had been inflated and was not refolded.The investigator was unable to inflate the balloon due to the damage noted to the shaft.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no damage to the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the radial cephalic vein.A 6.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after being inflated twice at 24 atmospheres, and the wire also became detached.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.

• 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: 22720842
• Report Number: 2124215-2025-53511
• Device Sequence Number: 13137057
• Product Code: LIT
• UDI-Device Identifier: 08714729793762
• UDI-Public: (01)08714729793762(17)280507(10)36458146
• 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): 10/28/2025

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: H74939171060670
• Device Catalogue Number: H74939171060670
• Device Lot Number: 0036458146
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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: 44 YR
• Patient Sex: Male