BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 5016650 · Received August 19, 2015

    Report

    Report Number
    3008203003-2015-00064
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 24, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A) 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

    THE 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 AT THE MIDDLE OF THE CASE A MAP SHIFT WITHOUT ERROR MESSAGE WAS EXPERIENCED. THE ISSUE WAS RESOLVED BY CREATING A NEW MAP. FOLLOW UP INVESTIGATION WAS PERFORMED TO CLARIFY THE EVENT AND IT WAS CONFIRMED THAT THE ISSUE OCCURRED WHILE MAPPING AND THAT THE MAP SHIFTED ABOUT ONE OR TWO INCHES. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS EVENT IS BEING REPORTED BECAUSE SUCH MAP SHIFTS POTENTIALLY CAUSED BY A SYSTEM MALFUNCTION, COULD MISLEAD THE PHYSICIAN AND POSSESSES A POTENTIAL RISK TO THE PATIENT. THE FIELD SERVICE ENGINEER (FSE) CONTACTED BWI REPRESENTATIVE REGARDING THE ISSUE. IT WAS DISCOVERED THAT THE CUSTOMER USED RE-STERILIZED LASSO NAV CATHETER (REPROCESSOR: STRYKER). FSE WAS ALSO INFORMED THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THERE WAS NO CARDIOVERSION. FSE SUGGESTED SENDING DATA FILES TO DEVICE MANUFACTURER (HTC) FOR ANALYSIS. THE BWI REPRESENTATIVE STATED THAT THE SPECIFIC COMPLAINT WAS RELATED TO A RE-STERILIZED CATHETER AND NOT RELATED TO THE SYSTEM. THE BWI REPRESENTATIVE EXPLAINED THAT THE ISSUE HAS NOT HAPPENED SINCE ORIGINAL COMPLAINT WAS PLACED AND CUSTOMER ALSO HAS NOT USED THE RE-STERILIZED LASSO CATHETERS SINCE. NO SERVICE REQUESTED. SYSTEM IS OPERATIONAL. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. 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 AT THE MIDDLE OF THE CASE A MAP SHIFT WITHOUT ERROR MESSAGE WAS EXPERIENCED. THE ISSUE WAS RESOLVED BY CREATING A NEW MAP. FOLLOW UP INVESTIGATION WAS PERFORMED TO CLARIFY THE EVENT AND IT WAS CONFIRMED THAT THE ISSUE OCCURRED WHILE MAPPING AND THAT THE MAP SHIFTED ABOUT ONE OR TWO INCHES. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS EVENT IS BEING REPORTED BECAUSE SUCH MAP SHIFTS POTENTIALLY CAUSED BY A SYSTEM MALFUNCTION, COULD MISLEAD THE PHYSICIAN AND POSSESSES A POTENTIAL RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548278 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1