BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENOVUS EMBOGUARD

    MDR report key: 16043553 · Received December 22, 2022

    Report

    Report Number
    MW5113994
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    December 18, 2022
    Report Date
    December 20, 2022
    Manufacturer
    CERENOVUS, INC. / NEURAVI LIMITED
    Product Code
    QJP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CERENOVUS EMBOGUARD - WHEN REMOVING FROM PATIENT THE OCCLUSION BALLOON SLID OFF OF THE CATHETER. IT WAS ALREADY COMING OFF BEFORE THE CATHETER WAS COMPLETELY REMOVED. OBVIOUSLY CONCERNING BECAUSE IN THE PATIENT IT WOULD HAVE EMBOLIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2742246 CERENOVUS EMBOGUARD CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP CERENOVUS, INC. / NEURAVI LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown