BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    158CM X 0.035IN ZOOM REPERFUSIO

    MDR report key: 19853113 · Received July 26, 2024

    Report

    Report Number
    MW5157734
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 21, 2024
    Report Date
    July 23, 2024
    Manufacturer
    IMPERATIVE CARE, INC.
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS BROUGHT TO THE (B)(6) FOR AN EMERGENCY THROMBECTOMY. AN ASPIRATION CATHETER WAS BEING USED FOR THROMBECTOMY, AND THE ASPIRATION CATHETER BROKE OFF AND REMAINED IN THE M3 SEGMENT. ATTEMPTS WERE MADE TO RECOVER THE CATHETER BUT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479748 158CM X 0.035IN ZOOM REPERFUSIO CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE, INC. ICRC035158 F2410801

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Other