BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIVI Q CATHETER

    MDR report key: 17931908 · Received October 13, 2023

    Report

    Report Number
    3011410509-2023-00005
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    August 29, 2023
    Report Date
    October 13, 2023
    Manufacturer
    MIVI NEUROSCIENCE, INC.
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN 85-YEAR-OLD MALE PATIENT PRESENTED WITH LEFT MCA OCCLUSION. PHYSICIAN ATTEMPTED 2 PASSES WITH REGULAR STENT AND 1 PASS WITH NIMBUS. HE USED Q5 CATHETER WITH REBAR AND SYNCHRO. ADVANCED Q5 OVER A REBAR TO THE THROMBUS. NEEDED TO ADVANCE 1MM MORE TO ENGAGE THROMBUS. REBAR WITH SYNCHRO KEPT PROXIMAL TO CLOT. DISSECTED AND RUPTURED MCA WITH Q5. PHYSICIAN STATED Q5 MIGHT HAVE BEEN SLIGHTLY OVERSIZED FOR THE PROCEDURE. COILED AND SACRIFICED VESSEL TO STOP BLEEDING. PATIENT HAD WORSENED STROKE SYMPTOMS AND IS STILL IN HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748636 MIVI Q CATHETER ASPIRATION CATHETER NRY MIVI NEUROSCIENCE, INC. Q5-57145-E M22120001

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Other| H| R