BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 506563 · Received January 8, 2004

    Report

    Report Number
    6000002-2004-00001
    Event Type
    Other
    Date Received
    January 8, 2004
    Report Date
    December 5, 2003
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE BALLOON RUPTURED DURING USE ON A PT AND PULLED OFF THE CATHETER. THE BALLOON HAD TO BE ASPIRATED FROM THE GRAFT VIA A SHEATH. NO PREMENENT PT INJURY REPORTED.

    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