BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2800768 · Received October 22, 2012

    Report

    Report Number
    3008203003-2012-00044
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A CORRECTION TO THE EVENT AND REPORTABILITY OF THIS COMPLAINT. THIS COMPLAINT WAS PROCESSED AS A REPORTABLE EVENT BECAUSE OF THE LOSS OF SIGNAL ISSUE. AFTER FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE LOSS OF SIGNAL ISSUE WAS A SEPARATE INCIDENT WHICH WAS PROCESSED UNDER THE BWI COMPLAINT MANUFACTURING NUMBER (B)(4). HOWEVER, IN REVIEWING COMPLAINT (B)(4), IT WAS DETERMINED THAT THIS COMPLAINT WAS NOT REPORTABLE PER THE RECORDED IMAGE THAT WAS PROVIDED FROM THE CUSTOMER. THE IMAGE SHOWS THAT THE SIGNAL ATTENUATION DIDN'T OCCUR ON ALL THE INTRACARDIAC (IC) RECORDINGS. THE LOSS OF SIGNAL ISSUE ONLY OCCURRED ON THE LASSO CATHETER, ABLATION CATHETERS AND THE BODY SURFACE (BS) ECG. THE FORCE MENU ISSUE FOR MANUFACTURER REFERENCE NUMBER (B)(4) IS NOT A REPORTABLE EVENT. EVALUATION SUMMARY. (B)(4). THE ISSUE FOR THIS COMPLAINT IS THAT THE FORCE MENU WAS NOT SHOWN AS THE TRIAL VERSION WAS GONE AND THEREFORE, THEY COULD NOT USE THE SMARTOUCH FEATURES. ADVISED AND TRAINED TO BUY THE SOFTWARE ST. SYSTEM IS OPERATIONAL. THE DEVICE HISTORY RECORD REVIEW SHOWED 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 THE FORCE MENU WAS NOT SHOWN. A REBOOT OF THE WORKSTATION WAS REQUESTED TO RESOLVE THE ISSUE. THEY WERE ALSO USING THE TRIAL VERSION. UPON REQUEST FOR ADDITIONAL CLARIFICATION ON CASE COMPLETION AND IF THERE WAS ANY PATIENT CONSEQUENCE, THE BIOSENSE WEBSTER FIELD REPRESENTATIVE STATED THAT THE ISSUE WAS RESOLVED BY CONNECTING THE PACING CABLE ABOVE THE REF/DECA INPUT +&-. THERE WERE NO PATIENT CONSEQUENCES, BUT IT WAS A DANGEROUS SITUATION AS THE INTRACARDIAC (IC) AND THE BODY SURFACE (BS) SIGNALS WERE LOST ON BOTH THE CARTO 3 SYSTEM AND THE EP RECORDING SYSTEM AT THE SAME TIME WHEN THE PHYSICIAN PUSHED THE FOOT PEDAL AND THE RADIOFREQUENCY STARTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1