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

Model Number	H74939171050440
Medical Device Problem Codes	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	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.E1 - initial reporter facility name: (b)(6).G4 - premarket / 510(k): k141521, k141597.
Event or Problem Description
It was reported that tip detachment occurred.The a 5.0 x 40, 40cm mustang balloon catheter was selected for use in a shunt percutaneous transluminal angioplasty (pta).Upon unpacking, it was noted that the distal tip has been cut diagonally.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.E1 - initial reporter facility name: (b)(6) medical center reported here as facility name exceeded character limit for designated field.G4 - premarket / 510(k): k141521, k141597.Device evaluated by mfr: the device was returned for evaluation.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.A visual examination of the markerbands identified no issues.A visual and tactile examination identified a shaft kink approximately 175mm proximal from the distal tip.A visual and tactile examination identified damage to the distal tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that tip detachment occurred.The a 5.0 x 40, 40cm mustang balloon catheter was selected for use in a shunt percutaneous transluminal angioplasty (pta).Upon unpacking, it was noted that the distal tip has been cut diagonally.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: 22922086
• Report Number: 2124215-2025-58243
• Device Sequence Number: 18430963
• Product Code: FGE
• UDI-Device Identifier: 08714729793731
• UDI-Public: (01)08714729793731(17)280415(10)36309943
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/24/2025

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: H74939171050440
• Device Catalogue Number: H74939171050440
• Device Lot Number: 0036309943
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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