BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 1024197 · Received March 27, 2008

    Report

    Report Number
    9673241-2008-00015
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    October 29, 2007
    Report Date
    October 31, 2007
    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
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION PROVIDED BY THE CUSTOMER WAS NOT INDICATIVE OF A REPORTABLE COMPLAINT. PRELIMINARY EVAL OF THE RETURNED COMPLAINT PRODUCT INDICATED THAT THE CATHETER WAS RETURNED LOCKED IN A DEFLECTED AND CONTRACTED POSITION. BIOSENSE WEBSTER BECAME AWARE OF THIS REPORTABLE MALFUNCTION UPON EVAL OF THE COMPLAINT PRODUCT ON 03/14/08. THE PRODUCT EVAL HAS NOT YET BEEN COMPLETED. THIS REPORT WILL BE UPDATED UPON COMPLETION OF PRODUCT EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS TAKEN OUT OF ITS PACKAGE, AND THE DOCTOR WAS UNABLE TO DEFLECT THE HANDLE.

    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 13259091

    Patients

    Seq Age Sex Outcome Treatment
    1