BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COR-KNOT

    MDR report key: 7946957 · Received October 5, 2018

    Report

    Report Number
    MW5080415
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    August 21, 2018
    Report Date
    October 4, 2018
    Manufacturer
    LSI SOLUTIONS, INC.
    Product Code
    GAS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE REPLACEMENT OF MITRL VALVE, THE PHYSICIAN PLACED THE COR-KNOT DEVICE AROUND THE SUTURE AND FOLLOWED THE STATURE DOWN TO THE VALVE. THE DEVICE MISFIRED, CUTTING THE SUTURE DISTALLY INSTEAD OF PROXIMALLY, CAUSING THE COR-KNOT TO FALL INTO THE RIGHT VENTRICLE. THE MITRAL VALVE 7300TFX29MM WAS REMOVED, CAUSING SIGNIFICANT DAMAGED TO THE VALVE. A SECOND MITRAL VALVE WAS OPENED AND SUCCESSFULLY SUTURED IN USING COR-KNOT 031082, LOT #708724.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778312 COR-KNOT SUTURE, NONABSORBABLE, SYNTHETIC POLYESTER GAS LSI SOLUTIONS, INC. 708724

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R