BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV

    MDR report key: 2032239 · Received March 5, 2011

    Report

    Report Number
    2032239
    Event Type
    Malfunction
    Date Received
    March 5, 2011
    Date of Event
    December 16, 2010
    Report Date
    March 5, 2011
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WOULD NOT BEND PROPERLY. THIS WAS AN INTRA-PROCEDURE FAILURE. OUR STAFF TESTS THESE CATHETERS PRIOR TO HANDING TO THE DOCTORS. A NEW CATHETER WAS HANDED OVER AND THE PROBLEM WAS RESOLVED. NO HARM CAME TO THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 NAV CATHETER, MAPPING, CARDIAC DRF BIOSENSE WEBSTER * 15254949L

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR