BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 2200179 · Received August 10, 2011

    Report

    Report Number
    9673241-2011-00082
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECEIVED CATHETER WAS VISUALLY INSPECTED AND IS IN GOOD CONDITION WITH NO DAMAGES. CATHETER WAS ELECTRICALLY TESTED AND FAILED DUE TO LEAKAGE ON ELECTRODE #2 AND #19. AFTER REMOVING THE CONNECTOR THE CATHETER WAS TESTED AGAIN AND THE LEAKAGE FROM ELECTRODE #2 AND #19 DISAPPEARED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. COMPLAINT CONDITION WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT DEVICE: CARTO 3 SYSTEM US CATALOG # FG540000 SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO BODY SURFACE OR INTRACARDIAC ECGS BEING DISPLAYED ON THE CARTO 3 OR RECORDING SYSTEM. REBOOTING CARTO AND THE RECORDING SYSTEM HAD NO EFFECT. IT WAS SUSPECTED THAT THE 12-LEAD GROUND WAS FAULTY. THE ON-CALL FSE WAS CONSULTED AND AGREED. IT WAS RECOMMENDED TO SWITCH THE LEADS AROUND TO CREATE A FUNCTIONING RIGHT LEG GROUND. THE 12 LEAD CABLE IN USE DID NOT ALLOW INDIVIDUAL LEAD REPLACEMENT. IN PREPARATION FOR ABANDONING THE CARTO 3, THE LASSO NAV CONNECTED TO 20B WAS DISCONNECTED AND ALL ECGS RETURNED. PLUGGING IN THE LASSO NAV TO 20A OR 20B RESULTED IN THE LOSS OF ALL ECGS. THE LASSO WAS REPLACED WITH ONE FROM A DIFFERENT LOT AND THE ECGS WERE NOT LOST. ISSUE RESOLVED.

    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. (JUAREZ) D-1290-01-S 15393256L

    Patients

    Seq Age Sex Outcome Treatment
    1