BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARTO XP EP NAVIGATION SYSTEM

    MDR report key: 1001138 · Received February 22, 2008

    Report

    Report Number
    9681484-2008-00002
    Event Type
    Death
    Date Received
    February 22, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 25, 2008
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K020863
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROFESSIONAL EDUCATION SPECIALIST (PROF ED) REVIEWED THE M1-M4 CHANNELS ON THE FRONT OF THE PT INTERFACE UNIT (PIU) WITH THE CUSTOMER. THE PROF ED EXPLAINED THAT THE FRONT M1-M4 WILL BYPASS THE PACING ROUTING SYSTEM IN CARTO AND WILL ALLOW THEM TO PACE DIRECTLY THROUGH THE CATHETER. THIS INFO IS ALSO CONTAINED IN THE CARTO XP USER MANUAL. CUSTOMER STATED THAT THEY WOULD LIKE TO TEST THIS OPTION BEFORE THEIR NEXT PROCEDURE. THE PROF ED ALSO RECOMMENDED ADDITIONAL INSERVICING OF THE EP LAB STAFF ON THIS METHOD.

    Description of Event or Problem · 1

    CUSTOMER CALLED BIOSENSE WEBSTER (BWI) TO REVIEW PACING PROTOCOL WHEN MAPPING CATHETER IS OUT OF RANGE. CUSTOMER REPORTED THE FOLLOWING: DURING AN ABLATION PROCEDURE USING THE CARTO XP SYSTEM, THE PROCEDURE BECAME A CODE SITUATION. WHEN THE BED WAS LOWERED TO PERFORM CPR, THE LOCATION MAGNET MOVED OUT OF THE MAPPING RANGE. CUSTOMER ALSO REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO PACE THROUGH THE MAPPING CATHETER, THE CATHETER WOULD NOT PACE DUE TO AN "OUT OF RANGE" ERROR MESSAGE. HOWEVER, AFTER NOTICING A SPIKE ON THE PRUKA SYSTEM, THE PHYSICIAN ASSUMED THE CATHETER WAS NOT CAPTURING, AND STARTED TO APPLY MORE FORCE ON THE CATHETER. THE PHYSICIAN WAS CONCERNED ABOUT PERFORATION AND THE FACT THAT THERE WAS NO ERROR MESSAGE ON THE CARTO STATING THAT THE MAPPING CATHETER WOULD NOT PACE WHILE OUT OF RANGE. PER CUSTOMER, THE PT REMAINED IN THE HOSP, AND THE PT'S CONDITION WAS DESCRIBED AS "NOT GREAT". SUBSEQUENT FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE PT DIED OF CARDIAC ARREST. PER CUSTOMER THE CARTO XP SYSTEM OR THE ABLATION DID NOT DIRECTLY CAUSE THIS EVENT AS THE PT WAS ALREADY SUFFERING FROM SEVERE CORONARY ARTERY DISEASE (CAD) AND WAS CHRONICALLY ILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO XP EP NAVIGATION SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4700-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Death PRUKA SYSTEM| NAVISTAR CATHETER