BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM

    MDR report key: 1232755 · Received November 14, 2008

    Report

    Report Number
    2953148-2008-00921
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 10, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE ATTRIBUTED TO THIS FAILURE MODE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS GRAFT SURGERY, ONCE HEARTSTRING SEAL WOULD NOT LOAD PROPERLY DURING LOADING OF THE HEARTSTRING DEVICE INTO THE DELIVERY TUBE. THE SURGEON PRESSED THE GREEN BUTTONS BUT THE SEAL DID NOT FOLD PROPERLY. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL SYSTEM DXC GUIDANT CARDIAC SURGERY HS-3045 8082771

    Patients

    Seq Age Sex Outcome Treatment
    1 NA