BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL

    MDR report key: 1031461 · Received April 18, 2008

    Report

    Report Number
    2953148-2008-00421
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 25, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE VISUAL INSPECTION SHOWED THAT THE SEAL WAS OUT OF THE DEPLOYMENT TUBE AND WAS UNRAVELED AND CRACKED. OTHER OBSERVATIONS WERE THAT THE TENSION SPRING COMPONENTS WERE LOADED INSIDE THE DEPLOYMENT TUBE AND THE FOAM COLLAR WAS BETWEEN THE PLUNGER. THE COMPLAINT WAS CONFIRMED FOR UNRAVELED SEAL. A LHR REVIEW WAS COMPLETED FOR THE PRODUCT AND THERE WAS NO NONCONFORMANCE ASSOCIATED WITH THE LOT NUMBER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS GRAFT SURGERY, TWO HEARTSTRING SEALS BEGAN TO UNRAVEL WHILE LOADING THE SEALS INTO THE DELIVERY TUBE. THE SURGEON CONVERTED TO CLAMP TO COMPLETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSP, AS A RESULT. THIS REPORT IS FOR THE FIRST SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL DXC GUIDANT CARDIAC SURGERY HS-1045 7060482

    Patients

    Seq Age Sex Outcome Treatment
    1 NA