BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 5043144 · Received August 31, 2015

    Report

    Report Number
    3008203003-2015-00069
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 6, 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
    SC, 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. CONTACT OFFICE AND MANUFACTURING SITE SHOULD REFLECT: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM. WHILE PERFORMING PLANNED PACING FROM THE MAP CATHETER, THERE WAS ALSO UNWANTED PACING BEING ROUTED THROUGH THE CORONARY SINUS CATHETER WHICH WAS PLUGGED INTO THE REFDECA PORT. WHEN THEY WERE SET TO PACE THROUGH THE CORONARY SINUS CATHETER, THERE WAS NO PACING ROUTED TO THE MAP CATHETER. THEY UNPLUGGED THE CORONARY SINUS CATHETER WHEN GOING ON ABLATION. THE SYSTEM DOES NOT HAVE DIRECT PACING AND PACING MUST BE SELECTED ON THE CARTO 3 SYSTEM. THE PROCEDURE CONTINUED AND THERE WAS NO PATIENT CONSEQUENCE REPORTED. DURING INVESTIGATION THE PACING CABLE WAS REPLACED BUT IT DID NOT RESOLVE THE ISSUE. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER ARRIVED TO THE ACCOUNT AND CONFIRMED THAT THE SYSTEM WAS ROUTING TO REF/DECA 5-6 REGARDLESS OF THE PORT SELECTED. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER REPLACED ECG CARD #1 AND THE ISSUE RESOLVED. ANNUAL SERVICE COMPLETED IN CONJUNCTION WITH REPAIR. ALL ACCEPTANCE TESTS PASSED AND SYSTEM WAS READY FOR USE. THE FAULTY ECG CARD WAS SENT TO THE DEVICE MANUFACTURER FOR INVESTIGATION. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ECG CARD WAS FOUND FAULTY. THE ECG CHANNELS 6,7,12 AND 14 WERE FOUND FAULTY OPTO SWITCHES THAT CAUSED THE REPORTED PROBLEM. THE DEVICE HISTORY REVIEW (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THE OPTO SWITCHES AND TVS FAILURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM AND UNWANTED PACING OCCURRED AND THE DIRECT PACING PORT WAS NOT WORKING. THEY HAD JUST UPGRADED THE SYSTEM TO V4.3. WHILE PERFORMING PLANNED PACING FROM THE MAP CATHETER, THERE WAS ALSO UNWANTED PACING BEING ROUTED THROUGH THE CORONARY SINUS CATHETER WHICH WAS PLUGGED INTO THE REFDECA PORT. WHEN THEY ARE SET TO PACE THROUGH THE CORONARY SINUS CATHETER, THERE IS NO PACING ROUTED TO THE MAP CATHETER. THE PACING SYSTEM WAS THE BLOOM. THEY UNPLUGGED THE CORONARY SINUS CATHETER WHEN GOING ON ABLATION. THE SYSTEM DOES NOT HAVE DIRECT PACING AND PACING MUST BE SELECTED ON THE CARTO 3 SYSTEM. THE PROCEDURE CONTINUED AND THERE WAS NO PATIENT CONSEQUENCE REPORTED. IF THE CATHETER IS PACING WHEN IT IS NOT REQUIRED OR THE DIRECT PACING PORT FAILS, THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS POSSIBLE. THEREFORE, THESE ISSUES WERE ASSESSED AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576029 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1