BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO RMT EP NAVIGATION SYSTEM V8

    MDR report key: 1082425 · Received July 21, 2008

    Report

    Report Number
    9681484-2008-00012
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BIOSENSE WEBSTER, LTD. (HAIFA, ISRAEL),
    Product Code
    DQK
    PMA / PMN Number
    K060047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS REPORTED UNDER THE CARTO SYSTEM. HOWEVER, THE DOCTOR BELIEVED THIS WAS CATHETER RELATED CASE. THE CATHETER HAS BEEN DISCARDED BY THE FACILITY. THE CATHETER WAS BELIEVED TO BE A NAVISTAR RMT 8MM. NO OTHER CATHETER DETAILED INFO WAS PROVIDED. WE WERE INFORMED THAT IT DOES NOT SEEM THAT MORE INFO REGARDING THE CATHETER CAN BE OBTAINED AT THIS POINT SINCE THE LABORATORY PERSONNEL THAT WAS IN CHARGE HAD LEFT THE FACILITY. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAS BEEN A LOCATION SHIFT (CATHETER MOVEMENT) ON THIS CARTO SYSTEM WHILE THE CASE WAS IN PROGRESS. THERE WAS NO PT INJURY REPORTED. PT FULLY RECOVERED WITH EXCELLENT PROGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO RMT EP NAVIGATION SYSTEM V8 COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD. (HAIFA, ISRAEL), M-5730-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK