BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3023758 · Received March 27, 2013

    Report

    Report Number
    3008203003-2013-00038
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    REFER TO EVALUATION SUMMARY. (B)(4). IT WAS REPORTED THAT AFTER 10 MINUTES OF ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE, THE ABLATION POINTS APPEARED 6.5 MM BELOW THE ORIGINAL MAP. THE CATHETER COULD NOT REACH THE ORIGINAL CS AND HIS TAGS TAKEN DURING MAPPING. THERE WERE NO ERRORS PRESENT, NO INDICATION OF PATIENT MOVEMENT AND NO WARNING MESSAGE FROM CARTO BEFORE THE SHIFTS. THE HEAD OF FLUOROSCOPY WAS NOT MOVED. ONLY THE MAGNETIC NAVIGATION CATHETER WAS DISPLAYED AND SHIFTED. BIOSENSE WEBSTER FIELD SERVICE ENGINEER CHECKED ALL CONNECTIONS AND TESTED THE SYSTEM. SYSTEM COMMUNICATED WITH THE LOCATION PAD CORRECTLY. CHECKED THE CAL-I VALUES AND THEY WERE ALL NORMAL. COMPLETED CUBE AND RELATIVE CLOUD TEST AND SYSTEM FUNCTIONED NORMALLY. THE FIELD SERVICE ENGINEER WAS NOT ABLE TO REPRODUCE THE ISSUES. IN ADDITION THE SYSTEM HAS BEEN UPGRADED AND IMAGED SINCE THIS EVENT SO THERE ARE NO LOG FILES FOR THIS CASE FOR FURTHER INVESTIGATION. SINCE THIS WAS A REPORTABLE EVENT, AN ADDITIONAL THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER 10 MINUTES OF ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE, THE ABLATION POINTS APPEARED 6.5 MM BELOW THE ORIGINAL MAP. THE CATHETER COULD NOT REACH THE ORIGINAL CS AND HIS TAGS TAKEN DURING MAPPING. THERE WERE NO ERRORS PRESENT, NO INDICATION OF PATIENT MOVEMENT AND NO WARNING MESSAGE FROM CARTO BEFORE THE SHIFTS. THE HEAD OF FLUOROSCOPY WAS NOT MOVED. ONLY THE MAGNETIC NAVIGATION CATHETER WAS DISPLAYED AND SHIFTED. NO CARDIOVERSION NOR PATIENT MOVEMENT PRIOR TO THE MAP SHIFT. THE REFERENCE PATCH WAS NOT MOVED. THE PHYSICIAN CHOSE TO CONTINUE THE CASE WITHOUT RESOLVING THE PROBLEM. THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126131 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1