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

Model Number	H74939171060810
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable bsed on the device analysis completed on 24apr2025.It was reported that the tip was not fully inflated.The target lesion was a stenosed segment located from the left superficial femoral artery to the popliteal artery.A mustang balloon catheter 6.0 mm x 80 mm, 135 cm length was selected for gradual dilatation.However, a mustang balloon 4.0 mm x 100 mm was also used for pre-dilatation.During the procedure, when the balloon reached the target lesion and inflation pressure reached 12 atmospheres, it was noted that the balloon tip did not fully inflate.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a balloon longitudinal tear.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection revealed that the balloon was not folded, indicating exposure to positive pressure.A longitudinal tear was identified in the balloon material, beginning approximately 22 mm distal to the proximal marker band and extending approximately 27 mm in the distal direction along the balloon surface.Due to the presence of this tear, balloon inflation was not possible.The rated burst pressure for this device is [insert value if available]; however, the observed failure occurred at a presumably lower pressure due to the structural compromise of the balloon.Visual and tactile examination of the device shaft revealed no kinks or structural damage.Similarly, no damage was observed at the distal tip upon visual and tactile inspection.Visual inspection confirmed that both marker bands were intact, undamaged, and properly positioned on 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: 22034810
• Report Number: 2124215-2025-31463
• Device Sequence Number: 15805647
• Product Code: LIT
• UDI-Device Identifier: 08714729793793
• UDI-Public: (01)08714729793793(17)270516(10)34043587
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141597
• 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): 05/16/2025

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: H74939171060810
• Device Catalogue Number: H74939171060810
• Device Lot Number: 0034043587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUODEWIRE - V18; SHEATH- 6F
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 77 KG