BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL

    MDR report key: 1052735 · Received May 23, 2008

    Report

    Report Number
    2953148-2008-00559
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 16, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSP DISCARDED THE PRODUCT. SINCE THE PRODUCT WAS NOT RETURNED TO CARDIAC SURGERY FOR EVAL, IT WILL BE DIFFICULT TO CONFIRM THE REPORTED PROBLEM. 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 HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING SEALS DID NOT DEPLOY OUT OF THE DELIVERY TUBE INTO THE AORTA. A REPLACEMENT HEARTSTRING SEAL WAS USED TO COMPLETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSP. THIS REPORT IS FOR THE SECOND SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL DXC GUIDANT CARDIAC SURGERY HS-1045 8011971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA