BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO XP EP NAVIGATION SYSTEM

    MDR report key: 1030783 · Received April 17, 2008

    Report

    Report Number
    9681484-2008-00008
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    BIOSENSE WEBSTER LTD. (HAIFA, ISREAL)
    Product Code
    DQK
    PMA / PMN Number
    K020863
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS COMPLAINT IS STILL ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF INVESTIGATION. ADD'L 510K #: K042999.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCATION OF THE NAVISTAR CATHETER AS DETERMINED BY X-RAY WAS NOT IN THE SAME PLACE ON THE CARTO MAP AFTER ABLATION. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY AND THE PROBLEM HAS NOT REOCCURRED.

    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, ISREAL) M-4700-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NAVISTAR CATHETER