BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT 4.3 MM AORTIC CUTTER

    MDR report key: 1023427 · Received April 2, 2008

    Report

    Report Number
    2953148-2008-00315
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 14, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL 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 CANNOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING CUTTER CUT THROUGH THE ANTERIOR AND POSTERIOR WALL OF THE AORTA. THE PT WAS PUT ON THE HEART LUNG MACHINE. THE SURGEON DEPLOYED THE HEARTSTRING SEAL IN THE ANTERIOR HOLE TO COMPLETE THE ANASTOMOSIS. THE POSTERIOR HOLE WAS REPAIRED BY SEWING A VEIN PATCH OVER THE HOLE. THE SURGEON DID NOT THINK THE PT EFFECT WAS RELATED TO THE DEVICE AND ADMITTED THAT THE PT'S AORTA WAS LESS THAN 2.5 CM. THE INSTRUCTION FOR USE-CONTRAINDICATIONS STATE, "DO NOT USE THE HEARTSTRING II PROXIMAL SEAL SYSTEM ON PTS WITH AORTAS LESS THAN 2.5CM IN DIAMETER." THE PT IS DOING FINE NOW AND IS EXTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT 4.3 MM AORTIC CUTTER DXC GUIDANT CARDIAC SURGERY HSK-2043 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention