BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR-KNOT

    MDR report key: 4091412 · Received July 24, 2014

    Report

    Report Number
    4091412
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    May 7, 2014
    Report Date
    July 24, 2014
    Manufacturer
    LSI SOLUTIONS, INC
    Product Code
    GAS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COR-KNOT DEVICE DID NOT DEPLOY PROPERLY, CAUSING THE WIRE TO BREAK WHILE ATTACHING THE MITRAL VALVE IMPLANT, THUS REQUIRING MANUAL REMOVAL OF THE WIRE, SUTURE & PLEDGET FROM THE IMPLANT PLACEMENT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432938 COR-KNOT SUTURE GAS LSI SOLUTIONS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR