BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE-WEBSTER E.P. CATHETER

    MDR report key: 1612108 · Received February 17, 2010

    Report

    Report Number
    MW5014822
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    January 13, 2010
    Report Date
    February 17, 2010
    Manufacturer
    BIOSENSE-WEBSTER J&J CO.
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC CATHETER ADVANCED THRU LONG SHEATH INTO PATIENT'S LEFT ATRIUM; REMOVED AND SET ASIDE. ON ATTEMPT TO RE-ADVANCE THE SAME CATHETER M.D. NOTED SHINY WIRE SHOWING THRU TRANSITION POINT OF CATHETER STOPPED BEFORE RE-ADVANCING INTO PATIENT. CATHETER REMOVED FROM FIELD AND REPLACED. NO PATIENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE-WEBSTER E.P. CATHETER DIAGNOSTIC E.P. CATHETER OAD BIOSENSE-WEBSTER J&J CO. 35T26R 15032061

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other