BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 6002704 · Received October 6, 2016

    Report

    Report Number
    6002704
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    April 12, 2016
    Report Date
    June 3, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ABLATION CATHETER WAS INSERTED INTO THE BODY AND ZEROED. AFTER IT WAS ZEROED THERE WAS A SENSOR ERROR ON THE CATHETER. WE TRIED UNPLUGGING AND RE-PLUGGING THE ELECTRICAL CABLE WITH NO SUCCESS. THE NEW CATHETER WAS HANDED OFF TO PHYSICIAN. THERE WAS NO FURTHER ISSUE WITH THE NEW CATHETER. A PRODUCT REP WITH BIOSENSE WEBSTER CALLED THE CATHETER IN. THE CATHETER WAS A BIOSENSE WEBSTER THERMOCOOL SMARTTOUCH D-F CAT # D132705 LOT 17325496M THE CATHETER DID NOT ZERO AND WAS GIVEN TO RETURN TO BIOSENSE. NO HARM TO THE PATIENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660577 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER DRF BIOSENSE WEBSTER, INC. SMARTTOUCH D-F 17325496M

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR