BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL CS-23-QL-PFO

    MDR report key: 501679 · Received December 15, 2003

    Report

    Report Number
    1222632-2003-00019
    Event Type
    Injury
    Date Received
    December 15, 2003
    Date of Event
    October 29, 2003
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IMPROPERLY DEPLOYED WITH BOTH SIDES IN THE LEFT ATRIUM DUE TO ANATOMICAL ANOMALY (MITRAL VALVE REPLACEMENT CAUSED SEPTUM PRIMUM TO PROLAPSE INTO THE RIGHT ATRIUM SO FAR THAT IT WAS IMPOSSIBLE TO SANDWICH SEPTUM). DEVICE WAS PULLED PARTIALLY INTO THE 11FR SHEATH AND PULLED DOWN TO THE 14FR BAIL OUT SHEATH. WHILE TRYING TO PULL THE IMPLANT INTO THE 14FR SHEATH, THE DEVICE RELEASED FROM THE DELIVERY CATHETER AND LODGED IN THE VEIN. AFTER ATTEMPTS TO RETRIEVE THE IMPLANT, THE PATIENT WAS SENT TO SURGERY WHERE THE DEVICE WAS SUCCESSFULLY RETRIEVED FROM THE SUBCUTANEOUS LAYER NEAR THE GROIN. PATIENT IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-23-QL-PFO CARDIOSEAL MLV NMT MEDICAL, INC. CS-23-QL-PFO 0310062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention