BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT 4.5MM HEARTSTRING PROXIMAL SEA;

    MDR report key: 604550 · Received May 17, 2005

    Report

    Report Number
    2953148-2005-00316
    Event Type
    Malfunction
    Date Received
    May 17, 2005
    Report Date
    May 12, 2005
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING SEALS DID NOT DEPLOY OUT OF THE DELIVERY TUBES INTO THE AORTA. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT 4.5MM HEARTSTRING PROXIMAL SEA; VASCULAR CLAMP DXC GUIDANT CARDIAC SURGERY HS-1045 4061082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA