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

Model Number	H74939171050440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.E1 - initial reporter address 1: (b)(6).G4 - premarket / 510(k) #: k141521, k141597.
Event or Problem Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel of the left forearm.A 5.0 x 40, 40cm mustang balloon catheter was advance for dilation.During the procedure, the balloon ruptured just before the fifth inflation at 24 atmospheres for 30 seconds.The device was removed without any problem, and the procedure was completed with a different device.There was no patient complications noted as a result of this event, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
Correction to field d4: lot number from 0034091704 to 0033371086.D2b - pro code (product code): fge, lit.E1 - initial reporter address 1: (b)(6).G4 - premarket / 510(k) #: k141521, k141597.
Event or Problem Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel of the left forearm.A 5.0 x 40, 40cm mustang balloon catheter was advance for dilation.During the procedure, the balloon ruptured just before the fifth inflation at 24 atmospheres for 30 seconds.The device was removed without any problem, and the procedure was completed with a different device.There was no patient complications noted as a result of this event, and the patient was in good condition after 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21963825
• Report Number: 2124215-2025-28732
• Device Sequence Number: 15766163
• Product Code: FGE
• UDI-Device Identifier: 08714729793731
• UDI-Public: (01)08714729793731(17)270206(10)33371086
• 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): 05/13/2025

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: H74939171050440
• Device Catalogue Number: H74939171050440
• Device Lot Number: 0033371086
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/13/2025
• Date Device Manufactured: 02/07/2024
• 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: GUIDEWIRE - RADIFOCUS 035; GUIDEWIRE - RADIFOCUS 035; INFLATION DEVICE - ENCORE 26; INFLATION DEVICE - ENCORE 26; INTRODUCER SHEATH - VAIVT ACE 5FR; INTRODUCER SHEATH - VAIVT ACE 5FR
• Patient Sex: Unknown