BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 448476 · Received March 13, 2003

    Report

    Report Number
    MW1027865
    Event Type
    Injury
    Date Received
    March 13, 2003
    Date of Event
    February 28, 2003
    Report Date
    March 13, 2003
    Manufacturer
    AFX
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ABLATION PROCEDURE WAS COMPLETE, THERE WAS NO PT INJURY NOR ANY CHANGE IN THE PLAN OF CARE.

    Description of Event or Problem · 1

    DURING MAZE ABLATION PROCEDURE AFTER 12TH USE OF THE FLEX 10 PROBE THE PROBE STARTED TO SMOKE. THERE WAS A PEA SIZE DARK BROWN CIRCLE ON PROBE WHERE SMOKE APPEARED. ONE COMPLETE CYCLE OF #1 THRU #10 THEN REPEAT OF #1 X2. RECORD OF TEMP REACHED 65 DEGREES CENTIGRADE DURING REPEAT OF #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX FLEX 10 ABLATION NEY AFX 102008-05 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R