BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLUENT CONSOLE

    MDR report key: 10759216 · Received October 29, 2020

    Report

    Report Number
    1222780-2020-00145
    Event Type
    Death
    Date Received
    October 29, 2020
    Date of Event
    September 30, 2020
    Report Date
    October 29, 2020
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIG
    UDI-DI
    15420045508552
    PMA / PMN Number
    K180825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRELIMINARY CLINICAL EVALUATION SUMMARY HAS BEEN PROVIDED BY THE GSS HEAD OF CLINICAL BASED ON THE INFORMATION AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE TM TO FORMULATE A FINAL CLINICAL EVALUATION SUMMARY: "IT IS UNLIKELY THAT EITHER DEVICE FLUENT MANAGEMENT SYSTEM OR MYOSURE PROCEDURE RESULTED IN OR CONTRIBUTED TO THE PATIENTS DEATH. THE CLINICAL HISTORY OF MULTIPLE DVT IN THE LE IS A RISK FACTOR AS WELL AS PATIENTS AGE AND WOULD PRE DISPOSE ANY PATIENT TO INCREASED RISK OF PE SPONTANEOUSLY OR WITH ANY SURGICAL INTERVENTION OR PROCEDURE REQUIRING ANESTHESIA , AND SHOULD HAVE BEEN CLEARED WITH A PRE-OPERATIVE H&P". DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED SERIAL NUMBER OF THE FLUENT CONSOLE. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFORMATION. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED OR DEVICE EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. CONCOMITANT MEDICAL PRODUCTS: SERIAL NUMBER OF THE MYOSURE TISSUE REMOVAL DEVICE NOT PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON SEPTEMBER 28TH DOCTOR PERFORMED A MYOSURE LITE PROCEDURE ON AN (B)(6) PATIENT WHO HAS HIGH BLOOD PRESSURE AND WAS POST MENOPAUSAL PATIENT TO OBTAIN SOME SAMPLES. THE DEFICIT DID NOT EXCEED 100 ON THE SYSTEM AND THE TECHS DID NOT DO A MANUAL COUNT. TWO DAYS LATER THE PATIENT PASSED AWAY FROM A PULMONARY EMBOLISM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219055 FLUENT CONSOLE INSUFFLATOR, HYSTEROSCOPIC HIG HOLOGIC, INC. RM-FLT-100 15420045508552

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MYOSURE TISSUE REMOVAL DEVICE - 30-401LITE