BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM INTERFACE CABLE

    MDR report key: 3957711 · Received July 25, 2014

    Report

    Report Number
    2029046-2014-00211
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF # (B)(4) ARE RELATED TO THE SAME EVENT. THE CONCOMITANT PRODUCTS: CARTO 3 SYSTEM MODEL # M-4800-01 SERIAL # (B)(4); SMART TOUCH BIDIRECTIONAL MODEL# D-1327-05-S, LOT # 16107500M.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE CUSTOMER GOT HIGH FORCE READING AND THE SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE ISSUE OCCURRED WHILE PREPARING TO ABLATE. THE CUSTOMER HAD FINISHED CONNECTING THE LEFT VEINS AND HAD THIS ISSUE POP UP WHEN GOING TO THE RIGHT SIDED PULMONARY VEINS. WHEN THEY WENT TO THE RIGHT SIDE AND HAD ONE HIGH FORCE READING AND IT APPEARED AS IF THE CATHETER WAS VISUALLY FLIPPING ACROSS THE SCREEN ON CARTO AND THE PHYSICAL MANIPULATION OF THE CATHETER. REPLACING THE CATHETER CABLE, REBOOTING THE PIU AND CHANGING THE CATHETER DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH CHANGING OUT THE CATHETER CABLE AGAIN WITHOUT ANY PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436719 CARTO® 3 SYSTEM INTERFACE CABLE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, INC (IRWINDALE) D-1286-03-S OEM_D-1286-03-S

    Patients

    Seq Age Sex Outcome Treatment
    1