BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 RMT SYSTEM

    MDR report key: 2071232 · Received April 27, 2011

    Report

    Report Number
    9681484-2011-00003
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED DIFFERENT FAILURES ON THIS COMPLAINT: ERRORS 8 AND 139 ON THE CARTO 3 SYSTEM; AND THE MICRO BUBBLES SEEN ON THE ULTRASOUND SYSTEM. AND THE UNIT WAS ALSO HAVING PROBLEMS WITH FAM OR TAKING ABLATION POINTS. THE CARTO 3 SYSTEM WAS REPLACED WITH ANOTHER UNIT. THE SYSTEM INVOLVED IN THIS COMPLAINT WAS THEN SENT TO THE TECHNOLOGY CENTER TO BE ANALYZED. THE ERROR MESSAGE (ERROR 8) AND MICRO BUBBLES ISSUES COULD NOT BE REPRODUCED. HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED AS THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE. ERROR 139 WAS RELATED TO CATHETER FUNCTIONALITY AND THE INVESTIGATION RESULT WAS RECORDED IN RELATED COMPLAINT (REPORT # 9673241-2011-00038 MFR (B)(4)). THE PROBLEM WITH FAM /TAKING ABLATION POINTS MAY ALSO BE CATHETER RELATED-- DEFECTIVE CATHETER WITH DISCONNECTED SENSOR MAY HAVE CAUSED IT TO BE IMPOSSIBLE TO BUILD FAM AND TAKE POINTS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. BIOSENSE WEBSTER MANUFACTURER'S REF NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REF NO.: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE USER ENCOUNTERED A PACE ROUTING ERROR CODE 8 ON THE CARTO SYSTEM. THERE WAS ALSO CURRENT LEAKAGE FROM THE LASSO NAV CATHETER FOR APPROXIMATELY TEN MINUTES . THE GENERATOR WAS SET TO POWER CONTROL MODE, AND THERE WAS NO ABLATION CATHETER IN THE LEFT ATRIUM. THEY WERE TRYING TO PACE THE CRISTA AND CS CATHETER. THE CURRENT WAS VISUALIZED AS BUBBLES FROM THE ULTRASOUND IMAGE. THIS CONTINUED AFTER THE SYSTEM WAS SHUT DOWN AND REBOOTED. THERE WAS NO PACING ATTEMPTED POST TRANSSEPTAL ACCESS. THE CARTO SYSTEM ALSO DISPLAYED ERROR CODE 139 (THE MAGNETIC SENSOR OF THE CATHETER IS DISCONNECTED). THE LASSO CABLE WAS EXCHANGED. THE PROBLEM PERSISTED. THE CUSTOMER WAS TRYING TO PACE THROUGH THE CRISTA CATHETER AND THE CS CATHETER AND WAS HAVING PROBLEMS. THE UNIT WAS ALSO HAVING PROBLEMS WITH FAM OR TAKING ABLATION POINTS. THERE WAS NO PATIENT INJURY REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO 3 RMT SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-5830-01

    Patients

    Seq Age Sex Outcome Treatment
    1