BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE REACH

    MDR report key: 17372468 · Received July 21, 2023

    Report

    Report Number
    1222780-2023-00252
    Event Type
    Death
    Date Received
    July 21, 2023
    Date of Event
    July 10, 2023
    Report Date
    July 21, 2023
    Manufacturer
    HOLOGIC, INC
    Product Code
    HIH
    UDI-DI
    15420045504530
    PMA / PMN Number
    K152723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: 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. H3: 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 AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. 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 ON JULY 10TH (DATE TO BE CONFIRMED) A PHYSICIAN WAS PERFORMING A MYOSURE PROCEDURE USING A FLUENT SYSTEM. THE PHYSICIAN HAD DIFFICULTY ENTERING THE CAVITY AND USED ULTRASOUND GUIDANCE TO LOCATE AND ENTER THE CAVITY. DURING THE PROCEDURE A PERFORATION OCCURRED AND THE PATIENT´S ILIAC ARTERY WAS CUT WITH THE MYOSURE DEVICE AND THE PATIENT STARTED TO LOOSE QUICKLY BLOOD. THE TRAUMA SURGICAL TEAM WAS BROUGHT TO THE ROOM AND THE PATIENT RECEIVED A TRANSFUSION. THE PATIENT WAS BROUGHT TO THE ICU FOR OBSERVATION AND FURTHER INTERVENTION AND THE PATIENT DIED A FEW DAYS AFTER THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE. THE DATE OF THE PROCEDURE AND DEATH ARE PENDING TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194161 MYOSURE REACH HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC 10-401FC 15420045504530

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death