BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3023770 · Received March 27, 2013

    Report

    Report Number
    3008203003-2013-00039
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 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
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, THE CARTO 3 WAS NOT SHOWING A RED NAVISTAR TIP DURING RF. A THERMOCOOL SF NAVISTAR WAS BEING USED TO ABLATE AT 30 WATTS. THE STOCKERT APPEARED TO BE FUNCTIONING NORMALLY AND WAS SENDING ABLATION DATA TO THE RECORDING SYSTEM. THE NAVISTAR ICON TIP REMAINED GREEN ON CARTO 3. THERE WAS NO IMPEDANCE CHANGE OR ELECTROGRAM REDUCTION WAS SEEN. RF WAS BEING DELIVERED EVEN THOUGH THE GREEN TIP WAS NOT TURNING RED. PACING WAS SET TO NONE AND THE ABLATION CHANNEL ON THE RECORDING SYSTEM WAS DISABLED. NORMAL IMPEDANCES WERE DISPLAYED ON STOCKERT. BIOSENSE WEBSTER FIELD SERVICE ENGINEER REPLACED THE BACKPLANE BOARD AND SET UP A WET BATH. FIELD SERVICE ENGINEER RAN FULL SYSTEM TEST AND THE SYSTEM PASSED IT SUCCESSFULLY AND THE SYSTEM WAS READY TO USE. THE DEFECTIVE BACKPLANE WAS REPLACED AND WAS SENT TO CARTO MANUFACTURER (HTC) FOR FURTHER INVESTIGATION. THE CARTO MANUFACTURER FOUND THAT A PIECE OF SOLDER SHORTED TWO PINS OF THE CONNECTOR P2 AND THIS CAUSED THE REPORTED ISSUE. THE BACKPLANE WAS SENT TO SUBCONTRACTOR FOR FURTHER REPAIR. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, THE CARTO 3 WAS NOT SHOWING A RED NAVISTAR TIP DURING RF. A THERMOCOOL SF NAVISTAR WAS BEING USED TO ABLATE AT 30 WATTS. THE STOCKERT APPEARED TO BE FUNCTIONING NORMALLY AND WAS SENDING ABLATION DATA TO THE RECORDING SYSTEM. THE NAVISTAR ICON TIP REMAINED GREEN ON CARTO 3. THERE WAS NO IMPEDANCE CHANGE OR ELECTROGRAM REDUCTION WAS SEEN. RF WAS BEING DELIVERED EVEN THOUGH THE GREEN TIP WAS NOT TURNING RED. PACING WAS SET TO NONE AND THE ABLATION CHANNEL ON THE RECORDING SYSTEM WAS DISABLED. NORMAL IMPEDANCES WERE DISPLAYED ON STOCKERT. CHANGING THE REDEL CABLE, REDEL ADAPTOR, NAVISTAR CABLE, NAVISTAR AND THE STOCKERT DID NOT RESOLVE THE ISSUE. THE CASE WAS COMPLETED BY CHANGING TO ANOTHER CARTO 3 AND THE NAVISTAR ICON TIP TURNED RED WITH ABLATION. NO PATIENT ADVERSE CONSEQUENCE IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126488 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1