BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIVI Q ASPIRATION CATHETER

    MDR report key: 13358931 · Received January 26, 2022

    Report

    Report Number
    3011410509-2021-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    March 8, 2021
    Report Date
    September 21, 2021
    Manufacturer
    MIVI NEUROSCIENCE, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSICIAN REPORTED ON A CASE IN THE M1 WHERE THE Q6 WAS USED WITH NEURON MAX 6F 088. MILD VESSEL TORTUOSITY WAS NOTED. A FOURTH THROMBECTOMY ATTEMPT WAS PERFORMED WITH THE SAME Q CATHETER AND A STENT RETRIEVER. WHILE RETRACTING THE Q CATHETER AND THE STENT RETRIEVER INTO THE NEURON MAX, IT WAS NOTED THAT THE Q CATHETER SEPARATED FROM THE WIRE. THE WIRE AND PROXIMAL END OF THE Q CATHETER WERE WITHIN THE NEURON MAX. THE STENT RETRIEVER WAS USED TO PULL THE REMAINING PORTION OF THE Q CATHETER INTO THE NEURON MAX. THEY PHYSICIAN REMOVED ALL DEVICES, INCLUDING THE NEURON MAX, AND SUCCESSFULLY RETRIEVED BOTH PIECES OF THE Q CATHETER WITHIN THE NEURON MAX. NO PATIENT INJURY WAS REPORTED. THE INCIDENT OCCURRED IN (B)(6) FOR THE Q ASPIRATION CATHETER. THE Q ASPIRATION CATHETER IS NOT AVAILABLE IN THE US: HOWEVER A CATHETER OF THE SAME DESIGN IS AVAILABLE IN THE US FOR DISTAL ACCESS, BUT NOT FOR ASPIRATION. THE PRODUCT WAS DISCARDED AND WAS NOT RETURNED FOR INVESTIGATION. THE IFU STATES TO LIMIT USE TO A MAXIMUM OF 3 PASSES. IT ALSO INCLUDES A PRECAUTION TO EXERCISE CARE WHEN HANDLING THE CATHETER BEFORE AND DURING THE PROCEDURE TO REDUCE THE POSSIBILITY OF DAMAGE.

    Description of Event or Problem · 0

    FIRST ASPIRATION WENT WELL, ONLY PART OF THROMBUS RETRIEVED. DURING 4TH MANEUVER, THE Q ASPIRATION CATHETER DETACHED FROM THE WIRE BUT WAS REMOVED EASILY DUE TO STENT RETRIEVER IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38554 MIVI Q ASPIRATION CATHETER ASPIRATION CATHETER DQY MIVI NEUROSCIENCE, INC. Q669145-E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown