BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO FOOT SWITCH

    MDR report key: 7852183 · Received September 6, 2018

    Report

    Report Number
    2134265-2018-60771
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    August 10, 2018
    Report Date
    September 6, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREMARKET / 510(K) # P920047, P980003, P020025.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOOTSWITCH FAILED TO STOP ENERGY DELIVERY. A MAESTRO 4000 FOOTSWITCH WAS SELECTED FOR A ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA ABLATION PROCEDURE. HOWEVER GENERATOR DID NOT STOP RF APPLICATION EVEN THE PHYSICIAN TOOK FOOT AWAY FROM THE PEDAL. THE RF APPLICATION STOPPED ITSELF AFTER 2-3 SECOND. AS SAFETY MEASURES THE PHYSICIAN PULLED THE CATHETER DIRECTLY INTO THE IVC. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694278 MAESTRO FOOT SWITCH CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC CORPORATION 86250

    Patients

    Seq Age Sex Outcome Treatment
    1