BEUDAMED
    FDA Adverse Event Other Summary report: N

    HERO VASCULAR ACCESS DEVCIE

    MDR report key: 2261477 · Received September 20, 2011

    Report

    Report Number
    3006945290-2011-00005
    Event Type
    Other
    Date Received
    September 20, 2011
    Date of Event
    March 20, 2011
    Report Date
    September 19, 2011
    Manufacturer
    HEMOSPHERE INC.
    Product Code
    DSY
    PMA / PMN Number
    K091491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VOL REPORT IS BEING SUBMITTED BECAUSE OF THE INCIDENTAL FINDING AT EXPLANT OF DEVICE DAMAGE. IT IS UNK IF THE DAMAGE OCCURRED DUE TO ITS LOCATION IN THE PT (SUBCLAVIAN VEIN AT THE JUNCTION OF CLAVICLE AND FIRST RIB) OR MANIPULATION DURING EXPLANT, OR MANIPULATION DURING THROMBECTOMY PROCEDURES, OR MANIPULATION DURING IMPLANT WHICH WAS DESCRIBED AS 'DIFFICULT' DUE TO MUCH STENOSIS. THE DAMAGE WAS DISCOVERED SECONDARILY AFTER EXPLANT AND THE SURGEON STATED THERE WERE NO ADVERSE EVENTS DIRECTLY LINKED TO OUR DEVICE AND HE WAS QUITE PLEASED WITH IT AND SAID THE DAMAGE WAS TO BE EXPECTED GIVEN ITS LOCATION AND MANIPULATION DURING THE IMPLANT. THIS DEVICE WAS RETURNED FROM (B)(6) AFTER BEING ABANDONED DUE TO OCCLUSION AND UNSUCCESSFUL THROMBECTOMY (B)(6) MONTHS AGO AND RECENTLY EXPLANTED PER INFECTIOUS DISEASE REQUEST DUE TO INFECTION OF ANOTHER DEVICE (TUNNELED DIALYSIS CATHETER). THE DEVICE WAS IMPLANTED FOR (B)(6) MONTHS. THE ARTICLES RETURNED ARE SHOWN. ALL OF THE DEVICE COMPONENTS EXCEPT FOR THE MAJORITY OF THE GRAFT WERE RETURNED. THE PORTION OF HERO OUTFLOW COMPONENT (OC) THAT IS STILL CONNECTED IS 40.7 CM. THE OC MUST HAVE BEEN CUT VERY CLOSE TO THE LUER AT THE TIME OF IMPLANT. THE OC IS FULLY CONNECTED, CUT SQUARE AND FLUSH WITH THE CONNECTOR SLEEVE. ONLY A VERY SHORT SEGMENT OF GRAFT WAS RETURNED. THE GRAFT IS DEFORMED (PERMANENTLY) IN THE BEADING REGION. OCCLUSIVE THROMBUS IS PRESENT IN GRAFT SEGMENT AND CONNECTOR AND SOME OF OC STILL ATTACHED. THERE IS EXTENSIVE DAMAGE TO THE OC BETWEEN 24 AND 28 CM (FROM THE TIP). THERE ARE NUMEROUS WIRE FRACTURES. THE LUMEN IS RUPTURED AND THE ENTIRE WALL IS OPEN ON ONE SIDE OF THE DEVICE. THERE ARE SITES OF SILICONE DAMAGE ABOVE INTACT NITINOL IN THIS AREA. THERE ARE ALSO WIRE BREAKS WITHIN SOMEWHAT INTACT SILICONE, HOWEVER, AT LEAST SOME OF THE WIRES HAVE SLID IN THE SILICONE FROM THEIR ORIGINAL POSITION. THERE APPEAR TO BE MISSING WIRE FRAGMENTS. THE THROMBUS OR MATERIAL IN THE OC LUMEN IN THIS REGION IS WHITE AND PINK IN COLOR. THE OC ALSO HAS SILICONE DAMAGE OVER THE CONNECTOR REGION. THIS COULD HAVE BEEN CAUSED BY A HEMOSTAT DURING CONNECTION AT IMPLANT.

    Description of Event or Problem · 1

    INCIDENTAL DAMAGE TO SOME NITINOL WIRES WAS NOTED AFTER EXPLANT IN BENT AREA ON HERO OUTFLOW COMPONENT THAT WAS PROBABLY IN REGION OF KINKED AREA UNDER THE CLAVICLE/FIRST RIB JUNCTION IN A SUBCLAVIAN IMPLANT, BUT NO IMAGES ARE AVAILABLE FOR CONFIRMATION. THE DEVICE HAD BEEN IMPLANTED AND WORKED FOR (B)(6) MONTHS, BUT THEN OCCLUDED AND THROMBECTOMY WAS UNSUCCESSFUL DUE TO KINK. DEVICE WAS ABANDONED AND TUNNELED DIALYSIS CATHETER INSERTED. (B)(6) MONTHS LATER, THE TUNNELED DIALYSIS CATHETER BECAME INFECTED AND INFECTIOUS DISEASE REQUESTED THAT BOTH DEVICES BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERO VASCULAR ACCESS DEVCIE DSY, LJS MSD DSY HEMOSPHERE INC. HERO 01001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR TUNNELED DIALYSIS CATHETER