BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER LASSO CATHETER

    MDR report key: 973215 · Received January 3, 2008

    Report

    Report Number
    9673241-2008-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2008
    Date of Event
    November 22, 2007
    Report Date
    December 6, 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
    PL
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER COULD NOT BE UNDEFLECTED DURING REMOVAL FROM THE PT. NO PT INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER LASSO CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1237-02-S 13260535

    Patients

    Seq Age Sex Outcome Treatment
    1 NI