BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3041709 · Received April 8, 2013

    Report

    Report Number
    3008203003-2013-00043
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN AF CASE, A MAP SHIFT WAS SEEN WITHOUT WARNING MESSAGE. THE MAP SHIFT WAS APPROXIMATELY 5 MM. A PATIENT MOVEMENT HAD BEEN OBSERVED. BOTH LASSO AND SMART TOUCH CATHETER SHIFTED IN SAME DIRECTION AND THE SAME AMOUNT OF SHIFT. ACL FUNCTION WAS IN USE DURING THE CASE. A REBOOT OF THE CARTO WORKSTATION IS NEEDED TO START A NEW STUDY AFTER DOING THE IMAGE INTEGRATION. FURTHERMORE, THE FAM STOPS AUTOMATICALLY DURING THE CASE WITHOUT ANY WARNING. THE PROCEDURE WAS COMPLETED BY REBOOTING AND RESTARTING FAM. ACCORDING TO CARTO 3 INSTRUCTIONS FOR USE, WHEN THE RELATIVE POSITION BETWEEN THE PATCHES REMAINS THE SAME BUT THE POSITION OF THE HEART RELATIVE TO THE BACK PATCHES HAS CHANGED (FOR EXAMPLE, AFTER REPOSITIONING THE PATIENT'S HEAD ON A PILLOW OR MOVING THE PATIENT'S ARM WITHOUT CHANGING THE PATIENT'S POSITION ON THE MATTRESS, OR AFTER THE PATIENT IS CARDIOVERTED), THE SYSTEM WILL NOT GIVE A WARNING AND AN INCORRECT MAP (MAP SHIFT) MIGHT BE GENERATED. IT WAS ALSO REPORTED THAT A REBOOT OF THE CARTO WORKSTATION WAS NEEDED TO START A NEW STUDY AFTER DOING THE IMAGE INTEGRATION. FURTHERMORE, THE FAM STOPPED AUTOMATICALLY DURING THE CASE WITHOUT WARNING. THE WORKSTATION WAS REPLACED WITH ANOTHER ONE, AND AS RESULT, THE PROBLEM WAS SOLVED. THE FURTHER INVESTIGATION COULDN'T BE PERFORMED AS THE REPLACED SUSPICIOUS WORKSTATION WAS LOST. DHR REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AF CASE, A MAP SHIFT WAS SEEN WITHOUT WARNING MESSAGE. THE MAP SHIFT WAS APPROXIMATELY 5 MM. A PATIENT MOVEMENT HAD BEEN OBSERVED. BOTH LASSO AND SMART TOUCH CATHETER SHIFTED IN SAME DIRECTION AND THE SAME AMOUNT OF SHIFT. ACL FUNCTION WAS IN USE DURING THE CASE. A REBOOT OF THE CARTO WORKSTATION IS NEEDED TO START A NEW STUDY AFTER DOING THE IMAGE INTEGRATION. FURTHERMORE, THE FAM STOPS AUTOMATICALLY DURING THE CASE WITHOUT ANY WARNING. THE PROCEDURE WAS COMPLETED BY REBOOTING AND RESTARTING FAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144112 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1