BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT HEARTSTRING III PROXIMAL SEAL

    MDR report key: 1063676 · Received June 20, 2008

    Report

    Report Number
    2953148-2008-00623
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 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
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE VISUAL INSPECTION SHOWED THAT THE SEAL HAD NOT UNRAVELED COMPLETELY. THE COMPLAINT WAS CONFIRMED. A LHR 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 AT THE COMPLETION OF THE CORONARY ARTERY BYPASS GRAFT PROCEDURE, ONE HEARTSTRING SEAL DID NOT UNRAVEL COMPLETELY DURING THE REMOVAL PROCESS. THE SEAL WAS REMOVED WITHOUT DAMAGING THE ANASTOMOSIS. NO PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT HEARTSTRING III PROXIMAL SEAL DXC GUIDANT CARDIAC SURGERY HS-3045 8021371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA