BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TICRON 10 X 30 CV-316 2/0 DA PGT 3 X 7

    MDR report key: 627233 · Received August 12, 2005

    Report

    Report Number
    9612501-2005-00032
    Event Type
    Injury
    Date Received
    August 12, 2005
    Date of Event
    May 1, 2005
    Report Date
    July 20, 2005
    Manufacturer
    SANTO DOMINGO-USS
    Product Code
    GAS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A MITRAL VALVE REPAIR A DURAN RING WAS DONE WITH TICRON VALVE SUTURES. UPON COMPLETION OF CASE, A TRANSESOPHAGEAL ECHO WAS DONE WHICH SHOWED FAILURE OF REPAIR. THE PT WAS RE-CANNULATED AND BACK ON CPB AND THE CHEST WAS RE-OPENED. ONE TICRON SUTURE WAS LOOSE AND THE OTHER WAS BROKEN. NEW SUTURES WERE PLACED, CASE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TICRON 10 X 30 CV-316 2/0 DA PGT 3 X 7 NONABSORBABLE BRAIDED POLYESTER SUTURE GAS SANTO DOMINGO-USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other