BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 11250795 · Received January 29, 2021

    Report

    Report Number
    11250795
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    December 4, 2020
    Report Date
    January 13, 2021
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE ARE REPORTING A TOTAL OF 41 EVENTS WITH DIFFERENT MODELS OF ABLATION CATHETERS BY BIOSENSE WEBSTER, WHICH OCCURRED IN THE PAST YEAR. IN THIS REPORT, WE HAVE LISTED 18 EVENTS OUT OF THE 41 EVENTS. OUT OF THE 18 EVENTS, 14 ARE RELATED TO PRODUCT MODEL/CATALOG# D133601 AND 4 ARE RELATED TO PRODUCT MODEL/CATALOG# D133602. THE DETAILS OF EACH EVENT ARE LISTED BELOW. BRAND NAME: THERMOCOOL SMARTTOUCH LOT NUMBER: MODEL/CATALOG#: ERROR CODE: 30273116M D133601 106 FORCE SENSOR ERROR. 30273116M D133601 TEMPERATURE SENSOR ERROR. 30293973M D133602 BAD/PARTIAL ECG. 30318154M D133602 NO TEMPERATURE READING. 30339205M D133601 NO TEMPERATURE READING. 30359432M D133601 HIGH FORCE, UNABLE TO ZERO. 30369189M D133601 BROKEN SPRING MECHANISM. 30377529M D133601 NOISY SIGNALS. 30377537M D133601 105 MAGNETIC SENSOR ERROR. 30383968M D133601 LOST ABILITY TO DEFLECT. 30383969M D133601 ERRATIC TEMPERATURE READINGS. 30383969M D133601 LOST ABILITY TO DEFLECT. 30383969M D133601 UNABLE TO CURVE. 30387224M D133601 HIGH TEMPS. 30401562M D133601 106 FORCE SENSOR ERROR. 30401562M D133601 UNABLE TO DEFLECT. 30401608M D133602 BROKEN STEERING MECHANISM. 30440520M D133602 NO SIGNAL POLES 3 AND 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149950 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. D133601 AND D133602

    Patients

    Seq Age Sex Outcome Treatment
    1