BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIVI Q CATHETER

    MDR report key: 16930548 · Received May 15, 2023

    Report

    Report Number
    3011410509-2023-00002
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Report Date
    May 15, 2023
    Manufacturer
    MIVI NEUROSCIENCE, INC.
    Product Code
    DQY
    UDI-DI
    B293Q6691450
    PMA / PMN Number
    K192558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A STROKE THROMBECTOMY PROCEDURE, THE PHYSICIAN ADVANCED THE Q6 CATHETER TO M1 CLOT WITH A 3MAX AND ASPIRATED THE CLOT. THE CLOT WAS RETRIEVED, AND THE PATIENT WAS READY FOR AN ANGIOGRAM. PHYSICIAN NOTICED THE MARKER BAND AFTER PERFORMING THE ANGIOGRAM. AFTER SEVERAL ATTEMPTS TO RETRIEVE THE MARKER BAND IN THE SHEATH IT ESCAPED AND LODGED BACK IN THE M1. THE PATIENT HAD TICI 3 AND THE PHYSICIAN OPTED TO LEAVE THE MARKER BAND AS ACUTELY IT WAS NOT AFFECTING FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184991 MIVI Q CATHETER DISTAL ACCESS CATHETER DQY MIVI NEUROSCIENCE, INC. Q6-69145 NOT KNOWN B293Q6691450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown