BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIVI Q CATHETER

    MDR report key: 17671119 · Received September 1, 2023

    Report

    Report Number
    3011410509-2023-00004
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    February 13, 2023
    Report Date
    September 1, 2023
    Manufacturer
    MIVI NEUROSCIENCE, INC.
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT A THROMBECTOMY PROCEDURE ON (B)(6) 2023 WITH THE USE OF Q6, MIVI SUPER 90, ASAHI 14 MICROWIRE, AND PENUMBRA 3MAX WAS USED TO ADVANCE THE Q CATHETER. THE CLOT LOCATION WAS NOTED TO BE IN THE MIDDLE CEREBRAL ARTERY, M1 ARTERY. IT WAS NOTED THAT THE PATIENT HAD DISTAL EMBOLI TO A DOWNSTREAM TERRITORY FROM M1 TO M3 DURING THE PROCEDURE AS NOTED BASED ON ANGIOGRAPHIC EVIDENCE, AND THE PHYSICIAN NOTED THAT THIS WAS PROBABLY RELATED TO THE USE OF THE Q6 DEVICE. THE EVENT MET THE SERIOUSNESS CRITERIA, AND NO TREATMENT WAS ADMINISTERED, AND SYMPTOMS RESOLVED WITHOUT CLINICAL SEQUALAE. MIVI WAS NOTIFIED OF SAE ON AUGUST 3, 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389501 MIVI Q CATHETER ASPIRATION CATHETER NRY MIVI NEUROSCIENCE, INC. Q6-69145-E M21010002

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other