BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 2769184 · Received October 2, 2012

    Report

    Report Number
    9673241-2012-00272
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K113213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FOLLOW-UP ATTEMPTS TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS, ON (B)(4) 2012 WE WERE NOTIFIED THAT THE CUSTOMER HAD DISCARDED THE CATHETER INVOLVED IN THIS COMPLAINT. THE DEVICE HISTORY RECORD WAS REVIEWED, AND WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT BWI PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM, MODEL #: M-4800-01 , SERIAL #: (B)(4). COOL FLOW IRRIGATION PUMP, MODEL #: M-5491-02, SERIAL #: (B)(4). STOCKERT RF GENERATOR, MODEL #:M-5463-01, SERIAL #: (B)(4). EZ STEER THERMOCOOL SF NAV CATHETER, MODEL #: D-1317-05-S, LOT #.: UNKNOWN. SOUNDSTAR 3D 10F-90 CATHETER, MODEL #: M-5723-05, LOT #.: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FIB PROCEDURE A CLOT WAS FOUND ON THE LASSO NAV VARIABLE CATHETER. THE CLOT WAS ASSESSED WITH THE INTRACARDIAC ULTRASOUND. THE PHYSICIAN ATTEMPTED TO ASPIRATE THE CLOT, HOWEVER, THE RESULT WAS UNCERTAIN. THERE WAS NO DEFINITE CLOT IN THE ASPIRATE. LATER ON THE ICE DID NOT SHOW ANY MORE CLOT. THE CASE WAS CONTINUED AND AT THE TIME OF THE CALL, THE PATIENT WAS STABLE WITH NO INJURY. THE ACT RANGE DURING THE PROCEDURE WAS REPORTED TO BE >350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-02-S 15619962L

    Patients

    Seq Age Sex Outcome Treatment
    1