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

Model Number	H74939171062010
Medical Device Problem Codes	Inflation Problem (1310); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): lit.G4 - pma/510(k) # field on 3500a form: k103751, k110122, k141521.
Event or Problem Description
It was reported that inflation and deflation issues occurred.The stenosed target lesion was located in the superficial femoral artery.A 6.0 x 200, 135cm mustang balloon catheter was advanced for dilatation.Two or three attempts were made to inflate the balloon.The balloon was not inflated until 8-10 atmospheres.The balloon was unable to fully inflate nor deflate.The procedure was completed using an alternate device.No patient complications were reported.
Event or Problem Description
It was reported that inflation and deflation issues occurred.The stenosed target lesion was located in the superficial femoral artery.A 6.0 x 200, 135cm mustang balloon catheter was advanced for dilatation.Two or three attempts were made to inflate the balloon.The balloon was not inflated until 8-10 atmospheres.The balloon was unable to fully inflate nor deflate.The procedure was completed using an alternate device.No patient complications were reported.It was further reported that it was fully removed as it was not able to inflated.
Additional Manufacturer Narrative
D2b - pro code (product code): lit.G4 - pma/510(k) # field on 3500a form: k103751, k110122, k141521.
Additional Manufacturer Narrative
D2b - pro code (product code): lit.G4 - pma/510(k) # field on 3500a form: k103751, k110122, k141521.The device was returned for evaluation.Visual inspection confirmed that the balloon was not folded, indicating prior exposure to positive pressure.The device was connected to an encore inflation unit and pressurized with deionized water to its rated burst pressure.No pressure loss or leakage was observed.A vacuum was subsequently applied, and the balloon fully deflated in 27 seconds, verified using digital timer, meeting the mustang specification requirement.The balloon was then inflated and deflated three additional times at its rated burst pressure, with no leaks observed.Evaluation of the balloon material revealed no abnormalities.Visual inspection of the markerbands and cutting blades identified no defects all blades were intact and securely bonded to the balloon surface.The tip exhibited no damage.Visual and tactile assessment of the catheter shaft found no defects.
Event or Problem Description
It was reported that inflation and deflation issues occurred.The stenosed target lesion was located in the superficial femoral artery.A 6.0 x 200, 135cm mustang balloon catheter was advanced for dilatation.Two or three attempts were made to inflate the balloon.The balloon was not inflated until 8-10 atmospheres.The balloon was unable to fully inflate nor deflate.The procedure was completed using an alternate device.No patient complications were reported.It was further reported that it was fully removed as it was not able to inflated.

• 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: 20762203
• Report Number: 2124215-2024-72913
• Device Sequence Number: 18457479
• Product Code: LIT
• UDI-Device Identifier: 08714729793380
• UDI-Public: 08714729793380
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2025

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: H74939171062010
• Device Catalogue Number: H74939171062010
• Device Lot Number: 0032593223
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 10/10/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/10/2024; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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