BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVX THROMBECTOMY SET

    MDR report key: 9779734 · Received March 3, 2020

    Report

    Report Number
    2134265-2020-02455
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    August 1, 2019
    Report Date
    March 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2019 AS IT WAS REPORTED THE EVENT HAPPENED 6+ MONTHS AGO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CODED. AN ANGIOJET AVX CATHETER WAS USED FOR TREATMENT. IT WAS REPORTED THAT THE PATIENT CODED AFTER USE OF THE ANGIOJET AVX. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243517 AVX THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention