BEUDAMED
    FDA Adverse Event Death Summary report: N

    RF FOOTSWITCH

    MDR report key: 7578779 · Received June 7, 2018

    Report

    Report Number
    1226420-2018-00165
    Event Type
    Death
    Date Received
    June 7, 2018
    Date of Event
    May 11, 2018
    Report Date
    June 7, 2018
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K073057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED; HOWEVER, FOLLOW-UP FOR INFORMATION IS STILL IN PROGRESS AND A SUPPLEMENTAL WILL BE SUBMITTED IF ADDITIONAL IS RECEIVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A BRONCHOSCOPY PROCEDURE, THE SURGEON IDENTIFIED THE LESION IN THE LEFT MAIN STEM BRONCHUS AND REMOVED PART OF THE LESION USING FORCEPS. THE SURGEON STARTED USING THE CORECATH DEVICE TO CONTROL THE BLEEDING. ONCE THE BLEEDING WAS CONTROLLED THE SURGEON SWITCHED TO CRYOTHERAPY TO FURTHER DEBULK THE TUMOR. DURING CRYOTHERAPY THE PATIENT BLEEDING INCREASED, AND THE SURGEON SWITCHED BACK TO THE CORECATH DEVICE WITHOUT RESOLUTION. THE PATIENT THEN EXPERIENCED A BLOOD CLOT TO THE LUNG AND CODED. CPR WAS INITIATED, AND THE PATIENT WAS RESUSCITATED. THE SURGEON REMOVED THE BLOOD CLOT AND CONTINUED TO DEBULK THE TUMOR USING CRYO. THE PATIENT CODED FOR THE SECOND TIME, RESUSCITATED AND SENT TO THE ICU, HOWEVER PASSED AWAY 48 HOURS DUE TO THE COMPLICATIONS RELATED TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421482 RF FOOTSWITCH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 34-109-1

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death