BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIVI Q DISTAL ACCESS CATHETER

    MDR report key: 15759928 · Received November 9, 2022

    Report

    Report Number
    3011410509-2022-00001
    Event Type
    Injury
    Date Received
    November 9, 2022
    Report Date
    November 9, 2022
    Manufacturer
    MIVI NEUROSCIENCE, INC.
    Product Code
    DQY
    UDI-DI
    B293Q3361630
    PMA / PMN Number
    K192558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ARRIVED WITH A CTA SHOWING A LEFT M2 OCCLUSION. IV THROMBOLYTIC WAS ADMINISTERED. ANGIOGRAM DEMONSTRATED THE CLOT MIGRATED TO M3. NEURON MAX, PHENOM 27, ARISTOLE 18 AND Q CATHETER WAS USED FOR ASPIRATION. A Q4 CATHETER WAS USED FIRST. THE Q4 CATHETER APPEARED TO BE OVERSIZED. AS THE MICROSYSTEM WAS REMOVED, THE Q4 PROLAPSED TO MAIN BRANCH AND LURCHED FORWARD. ASPIRATION WAS PERFORMED IN THE MAIN TRUNK. THE Q4 CATHETER WAS REPLACED WITH Q3 CATHETER. DUE TO PATIENT MOVEMENT A NEW DSA WAS REQUIRED. AN ANGIOGRAM WAS PERFORMED THROUGH THE Q3 CATHETER. THE ANGIOGRAM PUSHED CONTRAST INTO THE INFARCTED AREA. PATIENT HAD A HEMORRHAGIC CONVERSION DUE TO FORCEFUL INJECTION. THE CONVERSION REQUIRING HEMICRANIECTOMY AFTER THE PROCEDURE. PATIENT SHOWED FUNCTIONAL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262638 MIVI Q DISTAL ACCESS CATHETER DISTAL ACCESS CATHETER DQY MIVI NEUROSCIENCE, INC. Q3-36163 UNKNOWN B293Q3361630

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening