BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM

    MDR report key: 1232150 · Received November 14, 2008

    Report

    Report Number
    2953148-2008-00917
    Event Type
    Injury
    Date Received
    November 14, 2008
    Report Date
    November 6, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, THE HEARTSTRING SEAL DID NOT LOAD PROPERLY WHILE LOADING THE SEAL INTO THE DELIVERY TUBE. THE SURGEON CONVERTED TO CROSS-CLAMP TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED BY THE HOSPITAL AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL SYSTEM DXC GUIDANT CARDIAC SURGERY HS-3045 8071172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention