BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 5690694 · Received June 1, 2016

    Report

    Report Number
    5690694
    Event Type
    Malfunction
    Date Received
    June 1, 2016
    Date of Event
    March 24, 2016
    Report Date
    May 18, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS A CATHETER MALFUNCTION. WHEN THE CATHETER WAS INSERTED AND CONNECTED TO THE CABLE, THERE WAS NO SIGNAL DISPLAYED ON THE MONITOR. THE CATHETER WAS REMOVED AND A NEW CATHETER WAS USED. THE SECOND CATHETER WORKED FINE AND HAD SIGNAL DISPLAY. THE PROCEDURE COMPLETED SMOOTHLY AND NO INJURY TO THE PATIENT. MANUFACTURER RESPONSE FOR SMART TOUCH DD-F, BIOSENSE WEBSTER SMARTOUCH D-F (PER SITE REPORTER): NONE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345271 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. D132705 17377737M

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR