BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 6014204 · Received October 10, 2016

    Report

    Report Number
    3008203003-2016-00032
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 14, 2016
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND UNWANTED PACING OCCURRED AS THE MAPPING CATHETER WAS PACING WHILE ABLATING AT THE SAME TIME. FIELD SERVICE ENGINEER (FSE) WAS INFORMED BY BWI REPRESENTATIVE THAT THE ISSUE HAS BEEN GOING ON FOR 3 WEEKS WITHOUT BEING CALLED IN. FSE WENT ONSITE TO INVESTIGATE ISSUE. FSE EXCHANGED ECG CARD AND BACKPLANE CARD. FSE PERFORMED WET BATH AND ISSUE COULD NOT BE DUPLICATED. FSE RETURNED ORIGINAL BOARDS INTO THE SYSTEM. IT WAS DECIDED TO REPLACE THE SUSPECTED PIU + LP KIT AND TO SEND IT TO DEVICE MANUFACTURER FOR FURTHER INVESTIGATION. FSE REPLACED THE CUSTOMER¿S PIU +LP WITH A NEW KIT PIU + LP AND COMPLETED ALL REQUIRED ACCEPTANCE TESTS WITH SUCCESS. SYSTEM FUNCTIONING CORRECTLY AND IS READY FOR USE. REPLACED KIT PIU + LP WAS SENT TO HTC FOR INVESTIGATION. THE PIU +LP KIT WAS TESTED. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. NO FAILURE WAS FOUND. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND UNWANTED PACING OCCURRED AS THE MAPPING CATHETER WAS PACING WHILE ABLATING AT THE SAME TIME. THE PACING CABLE WAS NOT ATTACHED TO THE FRONT OF THE PATIENT INTERFACE UNIT. THE PACING LEADS WERE CONNECTED TO THE DIRECT STIMULATION PORT. PACING COULD OCCUR NORMALLY. HOWEVER, THE CATHETER WAS SHOWING RED AND ALSO HAD THE PACING ICON DISPLAYED. MICRO PACE PACING STIMULATOR WAS BEING USED DURING THE PROCEDURE. THE PACING WAS PLANNED PACING, HOWEVER UNWANTED PACING WAS BEING DELIVERED DURING ABLATION. THIS EVENT IS MDR REPORTABLE BECAUSE THERE IS A RISK TO DISORGANIZATION OF THE ELECTRICAL SIGNAL THAT COULD MISLEAD THE PHYSICIAN. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666915 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1