BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM

    MDR report key: 1190589 · Received October 6, 2008

    Report

    Report Number
    2953148-2008-00831
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 24, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSP DISCARDED THE PROD. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PROD. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE ATTRIBUTED TO THIS FAILURE MODE.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING SEALS DID NOT ROLL INTO THE DEPLOYMENT TUBES CORRECTLY AND AS A RESULT, THEY 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 FIRST SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL SYSTEM DXC GUIDANT CARDIAC SURGERY HS-3045 8071871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA