BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER SMARTTOUCH THERMOCOOL SF D-F CURVE ABLATION BIDIRECTIONAL

    MDR report key: 19980496 · Received August 14, 2024

    Report

    Report Number
    19980496
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ABLATION CATHETER MALFUNCTION DURING CASE. MANUFACTURER RESPONSE FOR ABLATION CATHETER, CATHETER SMARTTOUCH THERMOCOOL SF D-F CURVE ABLATION BIDIRECTIONAL (PER SITE REPORTER). VENDOR (BIOSENSE) TO REPLACE AT NO CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262422 CATHETER SMARTTOUCH THERMOCOOL SF D-F CURVE ABLATION BIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female