BEUDAMED
    FDA Adverse Event Death Summary report: N

    HERO VASCULAR ACCESS DEVICE

    MDR report key: 1720176 · Received June 9, 2010

    Report

    Report Number
    3006945290-2010-00007
    Event Type
    Death
    Date Received
    June 9, 2010
    Date of Event
    April 10, 2010
    Report Date
    June 9, 2010
    Manufacturer
    HEMOSPHERE INC.
    Product Code
    DSY
    PMA / PMN Number
    K091491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. THE HERO DEVICE WAS NOT BEING UTILIZED FOR DIALYSIS SINCE IT WAS STILL IN THE INCORPORATION PERIOD. THE FEMORAL CATHETER PLACED AT THE SAME TIME AS THE HERO WAS BEING UTILIZED FOR DIALYSIS ACCESS. AS WITH ALL (B) (6) PTS, THIS PT WAS AT HIGH RISK FOR ANY NUMBER OF SUDDEN DEATH EVENTS. SINCE NO AUTOPSY WAS PERFORMED, THE CAUSE OF DEATH IS UNK AND THEREFORE THE RELATIONSHIP OF THE DEATH TO THE HERO DEVICE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    PT DIED 2 DAYS AFTER PLACEMENT OF BOTH A FEMORAL TUNNELED DIALYSIS CATHETER AND A HERO VASCULAR ACCESS DEVICE IN THE UPPER EXTREMITY. NO AUTOPSY WAS PERFORMED SO CAUSE OF DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERO VASCULAR ACCESS DEVICE DSY, LJS, MSD DSY HEMOSPHERE INC. HERO 1001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death FEMORAL TUNNELED DIALYSIS CATHETER PLACED AT SAME| TIME AS HERO IMPLANT FOR DIALYSIS ACCESS WHILE| HERO DEVICE MATURED.