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

Model Number	H74939171050410
Medical Device Problem Codes	Material Rupture (1546); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k): k141521, k141597.
Event or Problem Description
It was reported that balloon burst occurred.The patient underwent subclavian artery stenting, with right femoral artery puncture.The 90% stenosed target lesion was located in the left subclavian artery.A 5.0 x 40, 135cm mustang balloon catheter was advanced for dilation.During pressurization, it was noted that the contrast medium in the pressure pump turned red and the balloon pressure did not go up.It was determined that the balloon might have burst.The balloon was removed from the patient's body, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon burst occurred.The patient underwent subclavian artery stenting, with right femoral artery puncture.The 90% stenosed target lesion was located in the left subclavian artery.A 5.0 x 40, 135cm mustang balloon catheter was advanced for dilation.During pressurization, it was noted that the contrast medium in the pressure pump turned red and the balloon pressure did not go up.It was determined that the balloon might have burst.The balloon was removed from the patient's body, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k): k141521, k141597.H6 - device codes: updated.

• 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: 24078806
• Report Number: 2124215-2026-02722
• Device Sequence Number: 5879448
• Product Code: FGE
• UDI-Device Identifier: 08714729793465
• UDI-Public: (01)08714729793465(17)270930(10)34952410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/18/2026

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: H74939171050410
• Device Catalogue Number: H74939171050410
• Device Lot Number: 0034952410
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/18/2026
• Date Device Manufactured: 09/30/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 58 KG