BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3071760 · Received April 22, 2013

    Report

    Report Number
    3008203003-2013-00052
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING AN ATRIAL FLUTTER (AFL) PROCEDURE, THERE WAS NOISE ON THE BODY SURFACE (BS) ECG¿S AND INTRACARDIAC (IC) SIGNALS. THE ABLATION CABLE WAS EXCHANGED AND THE NOISE DECREASED. THE PROCEDURE WAS OVER SO FURTHER TROUBLESHOOTING COULD NOT OCCUR. THE NOISE WAS STILL THERE EVERY 4TH TO 5TH BEAT. THE NOISE WAS ON THE CARTO 3 SYSTEM. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE NOISE WAS ON ALL THE BODY SURFACE (BS) ECG¿S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO 3 SYSTEM AND EP RECORDING SYSTEMS. THE NOISE WAS DISTORTED. IT WAS HARD TO READ THE EKG. THE PHYSICIAN WAS UNABLE TO INTERPRET THE SIGNALS WITH THE PRESENCE OF THE NOISE. THE NOISE OCCURRED WHEN THEY STARTED RF. THE DISTORTION WOULD STOP ONCE THEY WOULD STOP THE RF. ONCE THE CABLE WAS CHANGED, THE NOISE DECREASED TO EVERY 4TH OR 5TH BEAT. THEN THE PHYSICIAN FELT COMFORTABLE COMPLETING THE CASE. THE BWI FIELD SERVICE ENGINEER ADVISED THE BWI FIELD REPRESENTATIVE TO ISOLATE THE COOL FLOW PUMP TUBE FROM THE INDIFFERENCE ELECTRODE CABLE. THE BWI FIELD REPRESENTATIVE WAS TO ADVISE THE CUSTOMER FOR THE NEXT CASE. THE BWI FIELD SERVICE REPRESENTATIVE CONFIRMED THERE WAS NO NOISE ON THE BS OR IC SIGNALS DURING THE NEXT CASE. THE CASE WAS COMPLETED. THE CUSTOMER WAS SATISFIED WITH THE SIGNAL QUALITY. THE REPORTED ISSUE WAS AN ISOLATED EVENT CAUSED BY THE IMPROPER PATIENT SETUP. THE SYSTEM IS READY FOR USE. THE DEVICE HISTORY RECORD (DHR REVIEW OR INVESTIGATION) REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FLUTTER (AFL) PROCEDURE, THERE WAS NOISE ON THE BODY SURFACE (BS) ECG'S AND INTRACARDIAC (IC) SIGNALS. THE ABLATION CABLE WAS EXCHANGED AND THE NOISE DECREASED. THE PROCEDURE WAS OVER SO FURTHER TROUBLESHOOTING COULD NOT OCCUR. THE NOISE WAS STILL THERE EVERY 4TH TO 5TH BEAT. THE NOISE WAS ON THE CARTO 3 SYSTEM. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE NOISE WAS ON ALL THE BODY SURFACE (BS) ECG'S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO 3 SYSTEM AND EP RECORDING SYSTEMS. THE NOISE WAS DISTORTED. IT WAS HARD TO READ THE EKG. THE PHYSICIAN WAS UNABLE TO INTERPRET THE SIGNALS WITH THE PRESENCE OF THE NOISE. THE NOISE OCCURRED WHEN THEY STARTED RF. THE DISTORTION WOULD STOP ONCE THEY WOULD STOP THE RF. ONCE THE CABLE WAS CHANGED, THE NOISE DECREASED TO EVERY 4TH OR 5TH BEAT. THEN THE PHYSICIAN FELT COMFORTABLE COMPLETING THE CASE. THE SEVERITY OF THE NOISE ON ALL THE BODY SURFACE (BS) ECG'S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO 3 SYSTEM AND EP RECORDING SYSTEMS IS INDICATIVE OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171084 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1