BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 518134 · Received March 26, 2004

    Report

    Report Number
    6000002-2004-00059
    Event Type
    Other
    Date Received
    March 26, 2004
    Date of Event
    February 23, 2004
    Report Date
    February 27, 2004
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THROMBECTOMY OF THE LEFT ARM DIALYSIS GRAFT, THE BALLOON RUPTURED AND BROKE OFF IN THE PT'S GRAFT. REPORTEDLY THE PT REQUIRED SURGERY TO REMOVE THE FOREIGN MATERIAL, AFTER AN UNSUCCESSFUL ATTEMPT TO ASPIRATE FROM THE SHEATH. AT THE TIME OF THIS REPORT, THE PT'S CONDITION WAS REPORTED TO BE BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 120404F UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention