BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERO VASCULAR ACCESS DEVICE

    MDR report key: 2040932 · Received March 25, 2011

    Report

    Report Number
    3006945290-2011-00001
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 17, 2010
    Report Date
    March 29, 2011
    Manufacturer
    HEMOSPHERE, INC.
    Product Code
    DSY
    PMA / PMN Number
    K091491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE SURGEON COMMENTED THAT THE DEVICE DISCONNECTION WAS DISCOVERED INADVERTENTLY DURING ANOTHER PROCEDURE FOR REPLACING AN INFECTED TUNNELED DIALYSIS CATHETER, AND THAT THE PATIENT DID NOT HAVE ANY SYMPTOMS NOR ILL CONSEQUENCES AS A RESULT. THE SURGEON IS NOT TOO CONCERNED ABOUT THIS OCCURRING IN OTHER PATIENTS. HE FELT THIS PATIENT WAS UNIQUE DUE TO THE MULTIPLE STENTS AND SCAR TISSUE FROM SEVERAL PREVIOUS PROCEDURES, BUT HE IS UNABLE TO DETERMINE THE EXACT CAUSE OF THE DEVICE DISCONNECTION. POSSIBLE SOURCES OF THE DEVICE BECOMING DISCONNECTED COULD BE RELATED TO IMPROPER IMPLANT TECHNIQUE, SUCH AS LEAVING THE SILICONE LUER ATTACHED, OR SUBSEQUENT INTERVENTIONS SUCH AS THROMBECTOMY TECHNIQUE, OR SURGICAL PROCEDURES SUCH AS REMOVAL OF TUNNELED DIALYSIS CATHETERS. WE DIRECT SURGEONS IN OUR INSTRUCTIONS FOR USE TO REMOVE THE DEVICE IF IT IS NOT BEING USED FOR DIALYSIS. WE ALSO CAUTION PHYSICIANS TO NOT USE MECHANICAL THROMBECTOMY DEVICES FOR DECLOTTING THE DEVICE. ALSO IMPLANT TECHNIQUE COULD NOT BE EXCLUDED AS A FACTOR, SINCE THIS WAS THE FIRST HERO IMPLANT PERFORMED BY THIS SURGEON, AND IT IS POSSIBLE HE MAY NOT HAVE PROPERLY MADE THE CONNECTION BETWEEN THE GRAFT AND THE OUTFLOW COMPONENT.

    Description of Event or Problem · 1

    SIXTEEN MONTHS AFTER THE PATIENT WAS IMPLANTED WITH A HERO OUTFLOW COMPONENT THE DEVICE BECAME DISCONNECTED AT THE SHOULDER AND WAS EXPLANTED. THE DEVICE HAD BEEN IMPLANTED THROUGH THE LEFT SUBCLAVIAN VEIN INTO A LONG STENT INSIDE THE LEFT INNOMINATE VEIN AND INTO THE RIGHT ATRIUM OF THE HEART. THE DEVICE HAD NOT BEEN USED FOR DIALYSIS FOR ALMOST ONE YEAR, AFTER BEING RESECTED IN THE GRAFT PORTION DUE TO INFECTION ABOUT SIX MONTHS AFTER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERO VASCULAR ACCESS DEVICE DSY, LJS, MSD DSY HEMOSPHERE, INC. HE 4001 0000294

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention STENT IN BASILIC VEIN| TUNNELED DIALYSIS CATHETER| STENT IN INNOMINATE VEIN