BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO GRAFT

    MDR report key: 3946016 · Received July 21, 2014

    Report

    Report Number
    3006945290-2014-00049
    Event Type
    Injury
    Date Received
    July 21, 2014
    Report Date
    June 19, 2014
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO A MANUSCRIPT, THE END STAGE OF DIALYSIS ACCESS: FEMORAL GRAFT OR HERO VASCULAR ACCESS DEVICE, THERE WAS ONE CASE OF BACTEREMIA TREATED WITHOUT EXCISION OR ABANDONMENT. PRODUCT IS TERMINALLY STERILIZED BY A VALIDATED METHOD AND PCD'S WERE FOUND TO BE STERILE POST PROCESSING. THE MANUFACTURING RECORDS FOR LOTS, 0001742, 0001743, AND 0001747 WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. WITHOUT INFORMATION ABOUT THE TIMING AND SOURCE OF THE INFECTION, THE RELATIONSHIP OF THE INFECTION TO THE HERO GRAFT DEVICE IN DR. WONG'S PATIENT CANNOT BE DETERMINED. INFECTION IS A KNOWN POTENTIAL COMPLICATION LISTED IN THE HERO GRAFT INSTRUCTIONS FOR USE (IFU). THE HERO GRAFT IFU CONTRAINDICATES USE OF THE HERO DEVICE IN PATIENTS WITH KNOWN PREEXISTING BACTEREMIA. IN ADDITION, INSTRUCTIONS FOR SCREENING BLOOD CULTURES TO RULE OUT ASYMPTOMATIC BACTEREMIA AND RECOMMENDED ANTIBIOTIC THERAPY ARE ALSO PROVIDED IN THE IFU. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE AND THE IFU ADEQUATELY COMMUNICATES RISK.

    Description of Event or Problem · 1

    ACCORDING TO A MANUSCRIPT, THE END STAGE OF DIALYSIS ACCESS: FEMORAL GRAFT OR HERO VASCULAR ACCESS DEVICE, A PATIENT DEVELOPED BACTEREMIA AFTER HERO GRAFT IMPLANT.

    Description of Event or Problem · 1

    ACCORDING TO A MANUSCRIPT, THE END STAGE OF DIALYSIS ACCESS: FEMORAL GRAFT OR HERO VASCULAR ACCESS DEVICE, A PATIENT DEVELOPED BACTEREMIA AFTER HERO GRAFT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426318 HERO GRAFT VASCULAR GRAFT PROSTHESIS DSY HEMOSPHERE, INC. HERO 1002 0001742

    Patients

    Seq Age Sex Outcome Treatment
    1 Other