BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOOM 55 REPERFUSION CATHETER

    MDR report key: 19876023 · Received July 30, 2024

    Report

    Report Number
    MW5157834
    Event Type
    Death
    Date Received
    July 30, 2024
    Date of Event
    July 19, 2024
    Report Date
    July 26, 2024
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    NRY
    UDI-DI
    00812212030474
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING MECHANICAL THROMBECTOMY FOR ACUTE STROKE, THE DISTAL TIP OF ZOOM 55 CATHETER TIP SEPARATED. AFTER SUCCESSFUL RECANALIZATION, IT APPEARED THAT THE CATHETER TIP WAS RETAINED IN THE THROMBOSIS AND ULTIMATELY MIGRATED; RESULTED IN M1 OCCLUSION. MANY ATTEMPTS TO RETRIEVE CATHETER TIP WITH A VARIETY OF STRATEGIES WERE UNSUCCESSFUL. AN ARISTOTLE 24 GUIDEWIRE USED TO TRY TO OBTAIN THE BROKEN TIP ALSO FRACTURED AND CONTRIBUTED TO THE OCCLUSION. OCCLUSION COULD NOT BE CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911942 ZOOM 55 REPERFUSION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE INC. ICRC055137 F2408501 00812212030474

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| L| D