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

Model Number	H74939171061510
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - additional pro code (product code): lit g4 - additional premarket / 510(k): k110122, k141521.
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in the superficial femoral artery.A 6.0 x 150, 135cm mustang was used for dilation.The innova self-expanding stent was placed in the artery.When the balloon was advanced into the placed stent, it was noted that the balloon tip became stuck on the stent strut and the balloon catheter could not pass through.The procedure was completed with another of the same device.No patient complications were reported.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6128757234
• MDR Report Key: 21305824
• Report Number: 2124215-2025-05763
• Device Sequence Number: 8084177
• Product Code: FGE
• UDI-Device Identifier: 08714729793458
• UDI-Public: 08714729793458
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103751
• 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
• Report Date (Section B): 02/04/2025

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: H74939171061510
• Device Catalogue Number: H74939171061510
• Device Lot Number: 0035301645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2025
• Initial Report FDA Received Date: 02/04/2025
• Date Device Manufactured: 11/17/2024
• 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 Sex: Unknown