BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE SESNING ACCESS SHEATH (PSAS)

    MDR report key: 15813995 · Received November 17, 2022

    Report

    Report Number
    15813995
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    November 3, 2022
    Report Date
    November 10, 2022
    Manufacturer
    ENDOPHYS HOLDINGS, LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ENDOPHYS PRESSURE SENSING SHEATH FAILED TO DISPLAY ARTERIAL PRESSURE DURING STROKE PROCEDURE. THE SYSTEM WAS SET UP AND APPEARED TO BE READY FOR USE, BUT WHEN THE TIME CAME TO ZERO THE UNIT AND GET A READING, IT ONLY DISPLAYED THE MESSAGE PRESSURE VARIES. AT THIS TIME DURING THE PROCEDURE, THE SHEATH IS NOT EASILY SWITCHED OUT, AND THE CASE PROCEEDED WITHOUT THE ARTERIAL PRESSURE BEING MONITORED. THE TECH IN THE ROOM REACHED OUT TO THE VENDOR FROM ENDOPHYS AND WAS INSTRUCTED TO SAVE THE PRODUCT FOR FURTHER REVIEW BY THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178387 PRESSURE SESNING ACCESS SHEATH (PSAS) INTRODUCER, CATHETER DYB ENDOPHYS HOLDINGS, LLC 09F2200086

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA Female