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

Model Number	H74939171031510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code - lit.G4: pma/510(k) # field on 3500a form - k110122, k141521.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the renal artery.A 3.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured during gradual pressurization of the pressure pump.The device was removed without any issues, and the procedure was successfully completed using the same device.No patient complications were reported, and the patient was in good condition following the procedure.
Additional Manufacturer Narrative
D2b: pro code - lit.G4: pma/510(k) # field on 3500a form - k110122, k141521.Upon receipt at 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 24 atmospheres as per mustang specification.The returned device was connected to an encore inflation unit.Upon applying positive pressure, di water was observed leaking from a pinhole in the balloon, located approximately 80mm proximal to the distal tip.Visual inspection of the marker bands revealed no issues.Additionally, visual and tactile examinations confirmed no kinks or damage to the shaft, and no damage was identified on the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the renal artery.A 3.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured during gradual pressurization of the pressure pump.The device was removed without any issues, and the procedure was successfully completed using the same device.No patient complications were reported, and the patient was in good condition following the procedure.

• 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 ; 6512422111
• MDR Report Key: 21201307
• Report Number: 2124215-2025-02702
• Device Sequence Number: 7559562
• Product Code: FGE
• UDI-Device Identifier: 08714729794516
• UDI-Public: 08714729794516
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/12/2025

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: H74939171031510
• Device Catalogue Number: H74939171031510
• Device Lot Number: 0034091583
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 70 KG