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

Model Number	H74939171120470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit; g4 - premarket / 510(k) #: k141521, k141597.
Event or Problem Description
It was reported that balloon burst occurred.A 12.0 x 40, 75cm mustang was advanced for dilation.However, during the procedure, it was noted that the balloon burst before reaching the rated burst pressure (rb).The procedure was completed using another of the same device.
Event or Problem Description
It was reported that balloon burst occurred.A 12.0 x 40, 75cm mustang was advanced for dilation.However, during the procedure, it was noted that the balloon burst before reaching the rated burst pressure (rb).The procedure was completed using another of the same device.It was further reported that the target lesion was 70% stenosed, moderately tortuous, and moderately calcified axillary artery.Moreover, the balloon ruptured during second inflation at 18 atmospheres, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information d2b - pro code (product code): fge, lit.G4 - premarket / 510(k) #: k141521, k141597.

• 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: 20745470
• Report Number: 2124215-2024-73375
• Device Sequence Number: 8287225
• Product Code: FGE
• UDI-Device Identifier: 08714729793441
• UDI-Public: 08714729793441
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2024

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: H74939171120470
• Device Catalogue Number: H74939171120470
• Device Lot Number: 0034354963
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/01/2024
• Date Device Manufactured: 07/02/2024
• 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: 80 YR
• Patient Sex: Male