BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 5005116 · Received August 14, 2015

    Report

    Report Number
    3008203003-2015-00063
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    B) DUE TO FDA SHUT DOWN THEIR EMDR SERVER ALONG AUGUST 6TH ¿ AUGUST 10TH FOR MAINTENANCE AND THE 3500A CODES WERE UPDATED. WHILE BWI COMPLAINTS SYSTEM IS UPDATED, THE MAPPING WILL BE DONE MANUALLY. (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND VISITAG GRID DISAPPEARED MIDWAY THE PROCEDURE. THE ISSUE WAS RESOLVED WHEN CARTO WAS REBOOTED AND THE PROCEDURE COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE EVENT AND IT WAS INFORMED THAT ALL THE VISITAG POINTS DISAPPEARED WHILE PARAMETERS WERE BEING ADJUSTED AND WERE UNABLE TO RECOVER THEM. THE VISITAG INVESTIGATION IS IN PROCESS TO DETERMINE PATIENT RISK WHEN NOT FUNCTIONING PROPERLY; HOWEVER THAT INVESTIGATION IS NOT COMPLETE. THEREFORE, IN TAKING A CONSERVATIVE APPROACH THIS EVENT HAS BEEN ASSESSED AS REPORTABLE SINCE THIS ISSUE MAY POTENTIALLY LEAD TO INADVERTENT PROLONGED ABLATION IN SOME AREAS WHICH MIGHT RESULT IN THE PATIENT INJURY. THE USER RELOADED THE CARTO APPLICATION, AND AS A RESULT, THE ISSUE WAS RESOLVED. THE VISITAG POINTS APPEARED AGAIN. THE PROCEDURE WAS THEN CONTINUED. NO SERVICE WAS REQUESTED. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. MANAGEMENT IS NOTIFIED OF FAILURE ANALYSIS THROUGH THE MONTHLY TRENDING REPORTS. NO SIGNIFICANT TRENDS HAVE BEEN IDENTIFIED AT THIS TIME; THEREFORE NO CAPA ACTIVITY IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A CARTO 3 SYSTEM AND VISITAG GRID DISAPPEARED MIDWAY THE PROCEDURE. THE ISSUE WAS RESOLVED WHEN CARTO WAS REBOOTED AND THE PROCEDURE COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE EVENT AND IT WAS INFORMED THAT ALL THE VISITAG POINTS DISAPPEARED WHILE PARAMETERS WERE BEING ADJUSTED AND WERE UNABLE TO RECOVER THEM. THE VISITAG INVESTIGATION IS IN PROCESS TO DETERMINE PATIENT RISK WHEN NOT FUNCTIONING PROPERLY; HOWEVER THAT INVESTIGATION IS NOT COMPLETE. THEREFORE, IN TAKING A CONSERVATIVE APPROACH THIS EVENT HAS BEEN ASSESSED AS REPORTABLE SINCE THIS ISSUE MAY POTENTIALLY LEAD TO INADVERTENT PROLONGED ABLATION IN SOME AREAS WHICH MIGHT RESULT IN THE PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540678 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1