BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 1024195 · Received March 27, 2008

    Report

    Report Number
    9673241-2008-00013
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    December 12, 2007
    Report Date
    January 11, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K031161
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION PROVIDED BY THE CUSTOMER WAS NOT INDICATIVE OF A REPORTABLE COMPLAINT. PRELIMINARY EVAL OF THE COMPLAINT PRODUCT INDICATED THAT, AFTER DEFLECTING AND CONTRACTING THE CATHETER TEN TIMES, THE CATHETER BECAME LOCKED IN THE DEFLECTED AND CONTRACTED POSITION AND COULD NO LONGER BE UNDEFLECTED OR UNCONTRACTED. BIOSENSE WEBSTER BECAME AWARE OF THIS REPORTABLE MALFUNCTION UPON EVAL OF THE COMPLAINT PRODUCT OF 03/15/08. THE PRODUCT EVAL HAS NOT YET BEEN COMPLETED. THIS REPORT WIL BE UPDATED UPON COMPLETION OF PRODUCT EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LASSO CATHETER DID NOT DEFLECT AND THE RADIUS OF THE LASSO LOOP COULD NOT BE CHANGED. IT WAS ALSO REPORTED THAT THE PT DID NOT SUFFER FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1237-01-S 13236049

    Patients

    Seq Age Sex Outcome Treatment
    1