BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXPANDED PTFE STEPPED TAPER

    MDR report key: 615115 · Received June 16, 2005

    Report

    Report Number
    9612515-2005-00003
    Event Type
    Other
    Date Received
    June 16, 2005
    Date of Event
    March 24, 2005
    Report Date
    June 15, 2005
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EVENT OCCURRED DURING AN EMERGENCY OPERATION PROCEDURE TO IMPLANT A GRAFT FOR DIALYSIS. THE SURGEON PULLED THE GRAFT THROUGHT TISSUE USING DRESSING FORCEPS. THE GRAFT TORE ACCROSS THE GRAFT WHERE THE POLYPROPYLENE SUPPORT ENDED. NO DEATH OR SERIOUS INJURY. THE INCIDENT IS BEING REPORTED AS THE PROCEDURE WAS PROLONGED FOR ONE HOUR. THE SURGEON RE-ANASTOMOSED THE GRAFT, AS THERE WAS NO SPARE GRAFT FOR REPLACEMENT. THE GRAFT WAS NOT EXPLANTED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN KLINIK. THE EVENT OCCURRED DURING AN EMERGENCY OPERATION PROCEDURE TO IMPLANT A GRAFT FOR DIALYSIS. THE SURGEON PULLED THE GRAFT THROUGH TISSUE USING DRESSING FORCEPS. THE GRAFT TORE ACROSS THE GRAFT WHERE THE POLYPROPYLENE SUPPORT ENDED. NO DEATH OR SERIOUS INJURY OCCURRED AND THE INCIDENT IS BEING REPORTED AS THE PROCEDURE WAS PROLONGED FOR ONE HOUR. THE SURGEON RE-ANASTOMOSED THE GRAFT. THE GRAFT WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPANDED PTFE STEPPED TAPER VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA P03798/1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention