BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG?

    MDR report key: 24941254 · Received April 21, 2026

    Report

    Report Number
    2124215-2026-21477
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    April 15, 2026
    Report Date
    April 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729793861
    PMA / PMN Number
    K141521
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K) #: K141521, K141597.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON RUPTURED, REQUIRING ADDITIONAL INTERVENTION. THE 70% STENOSED AND FIBROTIC TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS VESSEL. A 7.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE IN A VENOPLASTY. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 20 ATMOSPHERES FOR 10 SECONDS. A BALLOON FRAGMENT THEN BECAME STUCK IN THE VESSEL AND THEN MIGRATED TO THE LUNG. AN X-RAY WAS USED TO TRY TO LOCATE THE FRAGMENT IN ORDER TO REMOVE IT. THEN A NON-BSC THROMBECTOMY CATHETER AND A SNARE WERE UNSUCCESSFULLY USED TO REMOVE THE FRAGMENT. THE PATIENT WAS HOSPITALIZED AND A PROCEDURE TO EXPLANT THE UNRETRIEVED DEVICE FRAGMENT WAS PERFORMED ON APRIL 16, 2026. THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004368 MUSTANG? STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE BOSTON SCIENTIFIC CORPORATION H74939171070670 0037636328 08714729793861

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization| R