BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE REACH TISSUE REMOVAL DEVICE

    MDR report key: 21152355 · Received January 14, 2025

    Report

    Report Number
    1222780-2025-00019
    Event Type
    Death
    Date Received
    January 14, 2025
    Date of Event
    December 13, 2024
    Report Date
    January 14, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    HIH
    UDI-DI
    15420045504530
    PMA / PMN Number
    K152723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21. CFR PART 803. THE SUBMISSION IS BASED UPON THE CURRENTLY AVAILABLE INFORMATION. THE SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONFIRMATION OF DEVICE MALFUNCTION INVOLVING THE HOLOGIC PRODUCTS IN THE EVENT DESCRIBED. LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE/MYOSURE PROCEDURE ON (B)(6) 2024. INITIALLY THE PHYSICIAN RESECTED A FIBROID WITH THE FLUENT PRO. THE PHYSICIAN WAS ABLE TO RESECT THE FIBROID AND ALMOST HIT THE 2500 DEFICIT LIMIT. MYOSURE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PHYSICIAN PERFORMED A NOVASURE PROCEDURE WITH A SUCCESSFUL ABLATION. THE PATIENT WAS DISCHARGED AT THE TIME AND APPEARED FINE. 2 DAYS LATER THE PHYSICIAN WAS EXAMINING THE PATHOLOGY SAMPLES AND NOTED THAT THE PATIENT HAD DECEASED DUE TO A CARDIAC ARREST ON (B)(6) 2024. NO OTHER INFORMATION IS AVAILABLE, MULTIPLE ATTEMPTS AT OBTAINING INFORMATION WERE NOT RESPONDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254832 MYOSURE REACH TISSUE REMOVAL DEVICE HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC 10-401FC UNKNOWN 15420045504530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death