BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 6146621 · Received December 5, 2016

    Report

    Report Number
    3008203003-2016-00040
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 9, 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 Location
    NY, 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)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM. NEAR THE END OF THE PROCEDURE DURING ABLATION, A MAP SHIFT OCCURRED. NO ERRORS WERE PRESENT. THERE WAS NO CARDIOVERSION PERFORMED NOR PATIENT MOVEMENT NOTED PRIOR TO THE MAP SHIFT. THE SIGNIFICANT MAP SHIFT OF APPROXIMATELY 3MM PLUS WAS NOTICED WHEN ABLATION POINTS BEGAN APPEARING IN THE MIDDLE OF THE FAST ANATOMICAL MAPPING GEOMETRY. THEY MADE A NEW LEFT ATRIUM MAP TO CONTINUE WITH THE PROCEDURE. THERE WERE NO FURTHER ISSUES AND NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER CONTACTED THE BIOSENSE WEBSTER FIELD REPRESENTATIVE REGARDING THIS ISSUE. THE BIOSENSE WEBSTER FIELD REPRESENTATIVE WAS COVERING THIS PROCEDURE. AFTERWARDS, THEY CONFIRMED THAT THE DEFIBRILLATION PAD WAS OVERLAPPING ONE OF THE C3 BACK PATCHES. ISSUE RESOLVED WHEN THE PATCHES WERE PLACED PROPERLY. THIS IS A USER ERROR ISSUE. SYSTEM IS OPERATIONAL. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM. NEAR THE END OF THE PROCEDURE DURING ABLATION, A MAP SHIFT OCCURRED. NO ERRORS WERE PRESENT. THERE WAS NO CARDIOVERSION PERFORMED NOR PATIENT MOVEMENT NOTED PRIOR TO THE MAP SHIFT. THE SIGNIFICANT MAP SHIFT OF APPROXIMATELY 3MM PLUS WAS NOTICED WHEN ABLATION POINTS BEGAN APPEARING IN THE MIDDLE OF THE FAST ANATOMICAL MAPPING GEOMETRY. THEY MADE A NEW LEFT ATRIUM MAP TO CONTINUE WITH THE PROCEDURE. THERE WERE NO FURTHER ISSUES AND NO PATIENT CONSEQUENCE. AFTERWARDS, THEY NOTED THAT THE DEFIBRILLATION PAD WAS OVERLAPPING ONE OF THE C3 BACK PATCHES. THE ISSUE RESOLVED WHEN THE PATCHES WERE PLACED PROPERLY. THIS EVENT HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION AS SUCH MAP SHIFTS WITHOUT AN ERROR MESSAGE COULD POTENTIALLY BE CAUSED BY A SYSTEM MALFUNCTION AND THERE WOULD BE A POTENTIAL RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796885 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1