BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAGARE

    MDR report key: 10851370 · Received November 17, 2020

    Report

    Report Number
    10851370
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 29, 2020
    Manufacturer
    KALILA MEDICAL, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER THE SURGEON'S EXPLANATION OF EVENT: THE LEFT AXILLARY ARTERY WAS EXPOSED AND A 12 FR SHEATH WAS PLACED. THROUGH THE 12 FR SHEATH A NEGARE STEERABLE SHEATH WAS PLACED AND A 100 CM BERENSTEIN CATHETER WAS PLACED THROUGH IT. I HAD TO GENERATE SIGNIFICANT AMOUNT OF TORQUE ON THE SHEATH AND IT KINKED. WHEN I TRIED TO REMOVE THE BERENSTEIN CATHETER THE FIRST 15-20 CM OF CATHETER BROKE AT THE KINK AND STAYED IN THE NEGARE. THE NEGARE WAS REMOVED WITH THE CATHETER TIP INSIDE AND PASSED OFF OF THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316957 NAGARE INTRODUCER, CATHETER DYB KALILA MEDICAL, INC. SS8FMB74 1660

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA