BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAE UNKNOWN AQUAMANTYS DEVICE

    MDR report key: 6248813 · Received January 13, 2017

    Report

    Report Number
    1226420-2017-00040
    Event Type
    Death
    Date Received
    January 13, 2017
    Date of Event
    April 1, 2010
    Report Date
    December 15, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ARTICLE: THE AQUAMANTYS® SYSTEM IMPROVES HEMOSTASIS AND PNEUMOSTASIS IN OPEN DECORTICATION FOR THORACIC EMPYEMA METHODS: DATA FOR ALL PATIENTS UNDERGOING OPEN DECORTICATION (OD) FOR STAGE II THORACIC EMPYEMA, USING EITHER CONVENTIONAL APPROACH OR FACILITATED BY USE OF THE AQUAMANTYS® DEVICE, AT A SINGLE THORACIC SURGICAL UNIT BETWEEN (B)(6) 2010 AND (B)(6) 2014, WERE RETROSPECTIVELY ANALYZED. UNPAIRED T-TEST AND FISHER¿S EXACT TEST WERE USED FOR STATISTICAL ANALYSIS. CONCLUSIONS: OUR DATA INDICATES THAT THE USE OF IRRIGATED TIP RF ABLATION IS SAFE AND EFFECTIVE IN IMPROVING PNEUMOSTASIS AND HEMOSTASIS IN DECORTICATION FOR THORACIC EMPYEMA; AND THAT THIS TRANSLATES TO MORBIDITY AND LOGISTICAL BENEFIT. POSTOPERATIVE OUTCOMES: PATIENTS IN THE AQUAMANTYS® GROUP EXPERIENCED LESS BLEEDING, A SHORTER DURATION OF POSTOPERATIVE AIR LEAK, AND A SHORTER LENGTH OF CRITICAL CARE AND HOSPITAL STAY. 22 PATIENTS REPORTED IN THE AQUAMANTYS GROUP. ADVERSE EVENTS: PATIENTS TRANSFUSED PRCS: 9 PATIENTS (42.9%) PULMONARY COMPLICATIONS: 4 PATIENTS (19.0%) NON-PULMONARY COMPLICATIONS: 5 PATIENTS (23.4%) MORTALITY: 1 PATIENT (4.8%) ALL PATIENTS ARE GROUPED INTO ONE EVENT DUE TO THE LACK OF UNIQUE PATIENT IDENTIFYING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31954 MAE UNKNOWN AQUAMANTYS DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK AQM DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death