MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG?; stents, drains and dilators for the biliary ducts

Model Number	H74939171051070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel in the left forearm.A 5.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.The first inflation was performed at 20 atmospheres and maintained for 2 minutes.During the second inflation at 10 atmospheres for 5 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25729361
• Report Number: 2124215-2026-36244
• Device Sequence Number: 18780125
• Product Code: FGE
• UDI-Device Identifier: 08714729793892
• UDI-Public: (01)08714729793892(17)290212(10)38591968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/03/2026

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: H74939171051070
• Device Catalogue Number: H74939171051070
• Device Lot Number: 0038591968
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2026
• 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: GUIDEWIRE: PROCYON.; INFLATION DEVICE: GM30.; INTRODUCER SHEATH: MEDIKIT.
• Patient Sex: Unknown