BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOGARTY

    MDR report key: 739976 · Received July 17, 2006

    Report

    Report Number
    739976
    Event Type
    Other
    Date Received
    July 17, 2006
    Date of Event
    June 9, 2006
    Report Date
    June 12, 2006
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2006 12:30PM (CLG5E8) WHILE DOING A FEMORAL EMBOLECTOMY, DR. PASSED A 3 FOGERTY CATHETER DOWN THE LEG. AFTER MEETING RESISTANCE, MANY ATTEMPTS MADE TO DEFLATE BALLOON. WHEN HE FINALLY PULLED THE CATHETER OUT, IT WAS NOTICED THAT THE BALLOON TIP HAD SHEARED OFF. DR. MADE SEVERAL ATTEMPTS TO RETRIEVE BALLOON TIP WITH NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY FOGARTY ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 120803F *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other