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

Model Number	H74939171060870
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11nov2025.It was reported that device difficulty in advancing occurred.The target lesion was located in the radial vessel.A 6.0 x 80, 75cm mustang was advanced for dilation.Prior to procedure, a lot of resistance were noted when advancing the sheath.However, returned device analysis revealed a balloon tear.
Additional Manufacturer Narrative
Device evaluated by mfr: the mustang was returned for analysis.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 40mm in length and extended from a position 45mm distal of the proximal markerband to 5mm distal of the distal markerband.The recommended introducer/guide sheath size for this device as per mustang product spec is minimum 5fr sheath.The sheath used by the customer was not returned for analysis.During analysis the investigator was unable to advance the device through 5fr boston scientific sheath due to the longitudinal tear in the balloon material as the investigator was unable to fully apply a vacuum to the device.A visual and tactile examination found no kinks or damage to the shaft of the returned device.A visual examination identified no damage to the tip of the device.

• 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: 23682539
• Report Number: 2124215-2025-87480
• Device Sequence Number: 9707475
• Product Code: FGE
• UDI-Device Identifier: 08714729793854
• UDI-Public: (01)08714729793854(17)270930(10)34953443
• 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
• Report Date (Section B): 12/01/2025

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: H74939171060870
• Device Catalogue Number: H74939171060870
• Device Lot Number: 0034953443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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: 68 YR
• Patient Sex: Male