BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING II PROXIMAL SEAL SYSTEM

    MDR report key: 1182661 · Received September 25, 2008

    Report

    Report Number
    2953148-2008-00812
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 4, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED. (B) (4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE CORONARY ARTERY BYPASS GRAFT SURGERY, THREE HEARTSTRING SEALS DID NOT DEPLOY OUT OF THE DELIVERY TUBE INTO THE AORTA. THE SURGEON DECIDED TO USE REGULAR CLAMP TO COMPLETE THE PROCEDURE. THE PATIENT HAD A BLOOD LOSS OF 600CC. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED BY THE HOSPITAL. THIS REPORT IS FOR THE SECOND SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING II PROXIMAL SEAL SYSTEM DXC GUIDANT CARDIAC SURGERY HS-1045 8051971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA