BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM 71 REPERFUSION CATHETER ASPIRATION CATHETER

    MDR report key: 11776701 · Received May 4, 2021

    Report

    Report Number
    MW5101166
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 30, 2021
    Report Date
    May 3, 2021
    Manufacturer
    IMPERATIVE CARE, INC.
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH COMPLETE MID-BASILAR ARTERY OCCLUSION DUE TO SEVERE CALCIFIED ATHEROSCLEROTIC DISEASE WAS UNDERGOING THROMBECTOMY. DURING THE PROCEDURE, THE TIP OF ZOOM 71 REPERFUSION CATHETER TIP DETACHED AND REMAINED RETAINED EVEN AFTER MULTIPLE ATTEMPTS MADE TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670842 ZOOM 71 REPERFUSION CATHETER ASPIRATION CATHETER CATHETER, THROMBUS RETRIEVER NRY IMPERATIVE CARE, INC. F2104102

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR