BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3160589 · Received June 10, 2013

    Report

    Report Number
    3008203003-2013-00070
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT REPAIR RECORD INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE, THE CARTO 3 SYSTEM LOST 12-LEAD ECG¿S SIGNALS FOR APPROXIMATELY 3-4 SECONDS AFTER CARDIOVERSION WAS PERFORMED IN THE PATIENT. IT WAS ALSO REPORTED THAT THE 12-LEAD AND INTRACARDIAC (IC) SIGNALS WERE FLAT WHEN THE PHYSICIAN WAS PACING FROM THE RV CATHETER CONNECTED TO REF/DECA. A BLUE PIN BOX WAS IN USE WITH REF/DECA. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE SIGNAL LOSS ISSUE BY BYPASSING THE CARTO 3 SYSTEM. THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES. THE BWI REPRESENTATIVE REPORTED LATER THAT THE ACCOUNT HAS DONE TWO CASES SINCE THE REPORTED INCIDENT AND THE PROBLEM DIDN'T DUPLICATE ITSELF DURING THESE CASES. IN ADDITION, THE COMPLAINT HISTORY OF THE SYSTEM WAS REVIEWED AND IT WAS FOUND THAT NO MORE SIMILAR PROBLEMS WERE REPORTED SO FAR. DHR REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE. THE DHR ASSOCIATED WITH CARTO 3 #13377 WAS REVIEWED AND THERE WERE NOT ANY DISCREPANCIES NOTED. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE, THE CARTO 3 SYSTEM LOST 12-LEAD ECG¿S SIGNALS FOR APPROXIMATELY 3-4 SECONDS AFTER CARDIOVERSION WAS PERFORMED IN THE PATIENT. IT WAS ALSO REPORTED THAT THE 12-LEAD AND INTRACARDIAC (IC) SIGNALS WERE FLAT WHEN THE PHYSICIAN WAS PACING FROM THE RV CATHETER CONNECTED TO REF/DECA. A BLUE PIN BOX WAS IN USE WITH REF/DECA. MOVING THE RV CATHETER DIRECTLY TO THE RECORDING SYSTEM RESOLVED THE PACING ISSUE. IT WAS RECOMMENDED TO TRY A DIFFERENT PIN BOX OR TO MOVE THE RV CATHETER TO PORT 20B WHEN ROUTED THROUGH CARTO 3 FOR TROUBLESHOOTING. THE REPORTER WAS NOT ABLE TO PERFORM A TROUBLESHOOTING AT THE TIME OF THE CALL. ADDITIONAL INFORMATION WAS REQUESTED TO THE CUSTOMER TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT AND IT WAS CONFIRMED THAT THE SIGNAL LOSS OCCURRED ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE SIGNAL LOSS ISSUE BY BYPASSING THE CARTO 3 SYSTEM. THE PACING PERFORMED IN THE PATIENT WAS PLANNED AND ACCORDING TO CUSTOMER¿S OPINION, IT APPEARED TO BE A HARDWARE ISSUE. BLOOM STIMULATOR WAS USED BY THE CUSTOMER IN THIS PROCEDURE. THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260020 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1