BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO RMT SYSTEM

    MDR report key: 1172016 · Received September 19, 2008

    Report

    Report Number
    9681484-2008-00017
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K042681
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETERS INVOLVED HAVE BEEN DISCARDED. (B) (4).

    Description of Event or Problem · 1

    A MAPPING OF THE LEFT ATRIUM AND PULMONARY VEINS WERE ACQUIRED IN RMT MODE WITH THE CARTO MERGE. UPON SHIFTING TO XP MODE, THE ABLATION POINTS TAKEN HAD SHIFTED 1 CM FROM THE PREVIOUSLY ACQUIRED POINTS. THE PROBLEM WAS NOT RELATED TO FLUOROSCOPY INTERFERENCE, BUT SEEMED TO BE RELATED TO THE FACT THE MAGNETS HAVE BEEN STOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO RMT SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-5300-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK