BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSRING II PROXIMAL SEAL SYSTEM

    MDR report key: 1081545 · Received July 25, 2008

    Report

    Report Number
    2953148-2008-00697
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 23, 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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. A LOT HISTORY RECORD REVIEW CANNOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ONE HEARTSTRING SEAL DID NOT DEPLOY OUT OF THE DELIVERY TUBE INTO THE AORTA. A REPLACEMENT HEARTSTRING SEAL WAS USED TO COMPETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSRING II PROXIMAL SEAL SYSTEM DXC GUIDANT CARDIAC SURGERY HS-1045 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA