BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELSOFT PLUS

    MDR report key: 1553765 · Received October 29, 2009

    Report

    Report Number
    9612515-2009-00010
    Event Type
    Other
    Date Received
    October 29, 2009
    Date of Event
    September 28, 2009
    Report Date
    October 30, 2009
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD - DEVICE TO BE EVALUATED. VISUAL EXAMINATION TO BE CARRIED OUT. THERE WERE A TOTAL OF TEN UNITS IN THE BATCH. ALL GRAFTS WERE GELATIN SEALED. AFTER SEALING, 100% OF ALL GRAFTS ARE WHOLE GRAFT POROSITY TESTED. THIS INVOLVES PRESSURIZING THE DEVICE WITH AN ISOPROPANOL ALCOHOL/GLYCEROL MIXTURE AND MEASURING THE FLOW RATE. THE MAXIMUM PERMISSIBLE FLOW RATE WAS DETERMINED BY COMPARISON WITH CITRATED COWS BLOOD. THE QUALITY CONTROL AND MFG RECORDS HAVE BEEN REVIEWED AND THERE IS NOTHING TO SUGGEST ANY PROBLEMS. THE LEAK TEST RESULTS WERE WITHIN OUR SPECIFIED QUALITY CONTROL LIMITS FOR THIS PRODUCT. ALL DEVICES FROM THIS BATCH WERE DISTRIBUTED IN JANUARY 2008. NO OTHER REPORTS HAVE BEEN RECEIVED FOR THE OTHER UNITS. THE USAGE RATE OF THESE DEVICES IS SUCH THAT WE CAN ASSUME THAT ALL OF THESE DEVICES HAVE BEEN IMPLANTED. THE GRAFT HAS BEEN RETURNED TO VASCUTEK FOR ANALYSIS.

    Description of Event or Problem · 1

    THE EVENT HAPPENED AT (B)(6), THERE WAS NO DEATH OR SERIOUS INJURY. THE EVENT IS BEING REPORTED, DUE TO INTERVENTION BEING REQUIRED. THE PT HAD A FEMORAL ANEURYSM AND HAD PREVIOUSLY HAD A VEIN GRAFT BYPASS FOR A POPLITEAL ANEURYSM. THE GRAFT WAS TUNNELLED UNDER THE SKIN FROM THE GROIN TO THE VEIN GRAFT WHICH WAS LOCATED AROUND THE PT'S KNEE. THE PROXIMAL ANASTOMOSIS WAS MADE AND A CLAMP WAS PLACED ON THE DISTAL END OF THE GRAFT. WHEN THE BLOOD WAS ALLOWED TO FLOW INTO THE GRAFT AND PRESSURISED, BLOOD LEAKAGE WAS NOTICED AT THE DISTAL END OF THE GRAFT. THE GRAFT WAS REMOVED AND ANOTHER VASCUTEK GRAFT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELSOFT PLUS VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNK 84885 0614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention