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

Model Number	H74939171080670
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 21oct2025.It was reported that the difficulty advancing occurred.An 8.0 x 60, 75cm mustang was selected for percutaneous transluminal coronary angioplasty (pta).However, during the procedure, it was noted that resistance was felt when advancing into the sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed a pinhole leak in the shaft located approximately 135mm proximal from the distal tip.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k): k141521, k141597.Device evaluated by mfr: the mustang device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 20 atmospheres as per mustang specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from a pinhole leak in the shaft located approximately 135mm proximal from the distal tip.The recommended introducer/guide sheath size for this device as per mustang product specification is minimum 5fr sheath.The investigator was unable to apply a vacuum due to the shaft leak and was unable advance the device through the introducer sheath.The sheath used by the customer was not returned for analysis.A leak test confirmed a shaft leak and multiple shaft kinks were noted.A visual examination identified no damage to the tip of the device.This concludes the product analysis.

• 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: 23556047
• Report Number: 2124215-2025-83095
• Device Sequence Number: 13176653
• Product Code: FGE
• UDI-Device Identifier: 08714729793885
• UDI-Public: (01)08714729793885(17)270625(10)34306513
• 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): 11/14/2025

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: H74939171080670
• Device Catalogue Number: H74939171080670
• Device Lot Number: 0034306513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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: 67 YR
• Patient Sex: Female