BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 2583910 · Received May 22, 2012

    Report

    Report Number
    2029046-2012-00067
    Event Type
    Malfunction
    Date Received
    May 22, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 1, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCT: CARTO 3 MODEL# M-4800-01 SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED DEVICE WAS EVALUATED FOR ELECTRICAL RESISTANCE AND CURRENT LEAKAGE AND IT PASSED MEETING SPECIFICATIONS. A VISUAL INSPECTION WAS PERFORMED AND IT WAS OBSERVED THAT THE CATHETER HAD LIGHT GREEN RESIDUES BUILT UP ON THE CONNECTOR PINS THAT MAY HAVE CONTRIBUTED TO THE NOISE ISSUE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND REGARDING THIS ISSUE. DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE COMPLAINT CONDITION COULD NOT BE CONFIRMED; HOWEVER, RESIDUES BUILT UP ON THE CONNECTOR PINS WERE FOUND WITH AN UNKNOWN ORIGIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE CARTO3 SYSTEM WAS DISPLAYED RED LIGHT INDICATORS OVER ECG1 AND ECG3 ON THE PIU. THE SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE ECGS AND ALL IC (INTRACARDIAC) RECORDINGS ON BOTH CARTO AND EP RECORDING SYSTEMS AT THE SAME TIME. ALL RECORDINGS WERE FLAT LINE WITH INTERMITTENT SPIKES OF NOISE. THE CUSTOMER STATED THAT THERE WAS SEVERAL ERROR CODES WERE DISPLAYED ON THE WORK STATION. THE FIRST WAS AN ERROR 8, "PACE ROUTING DISABLED" AND AFTER A REBOOT, ERROR 21, "BIT TEST FAILED ON PIU; FAILURE IN THE ECG CARD 3" WERE APPEARED. THE USER WAS ADVISED TO PERFORM THE FOLLOWING: TURN OFF THE PIU. UNPLUG ALL SENSOR BASED CATHETERS FROM THE PIU. TURN THE PIU ON. RECONNECT EACH SENSOR BASED CATHETER ONE AT A TIME AFTER THE PIU IS FULLY INITIALIZED. THE USER CONNECTED EACH ONE BACK AND IT WAS NOTED THAT AFTER THE LASSO CATHETER WAS CONNECTED, AN ERROR 1201 WAS SEEN, "LIMB LEAD DISCONNECTED". UNPLUGGING THE LASSO CATHETER RESOLVED THE ERROR IMMEDIATELY. THE USER WAS ADVISED TO REPLACE THE LASSO CATHETER. THE ISSUE RESOLVED AND THE CASE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1290-01-S UNKNOWN_D-1290-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1