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

Model Number	H74939171061010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code - lit.G4: pma/510(k) # field on 3500a form - k141597.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified common iliac artery.A 6.0 x 100, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured in first inflation at 15 atmospheres.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
D2b: pro code - fge, lit.G4: pma/510(k) # field on 3500a form - k141597.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified common iliac artery.A 6.0 x 100, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the baalloon ruptured in first inlflation at 15 atmospheres.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.It was further reported that the balloon ruptured for 60 seconds.

• 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: 21123751
• Report Number: 2124215-2024-83411
• Device Sequence Number: 12621566
• Product Code: FGE
• UDI-Device Identifier: 08714729793540
• UDI-Public: 08714729793540
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141521
• 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): 01/31/2025

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 Expiration Date: 07/23/2026
• Device Model Number: H74939171061010
• Device Catalogue Number: H74939171061010
• Device Lot Number: 0032073187
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 01/31/2025
• Date Device Manufactured: 07/24/2023
• 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