BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 8421178 · Received March 14, 2019

    Report

    Report Number
    2134265-2019-02441
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 18, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889045
    PMA / PMN Number
    K133629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SEPARATED INSIDE THE PATIENT. AN ANGIOJET AVX CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. AT THE COMMENCEMENT OF THE PROCEDURE WHEN THE CATHETER WAS INSIDE THE PATIENT'S BODY, THE TIP PARTIALLY SEPARATED FROM THE CATHETER. THE WIRE WAS ALSO NOTED TO BE COMING OUT OF THE SIDE OF THE TIP. THE CATHETER AND TIP WERE THEN SUCCESSFULLY REMOVED COMPLETELY FROM THE PATIENT WITHOUT COMPLICATION. A NEW DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT WAS FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213319 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 22568689 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1