BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILUME BPH CATHETER SYSTEM

    MDR report key: 20908631 · Received December 11, 2024

    Report

    Report Number
    3015228875-2024-00004
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 11, 2024
    Manufacturer
    UROTRONIC INC.
    Product Code
    QXB
    PMA / PMN Number
    P220029
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 11/11/2024 UROTRONIC RECEIVED INFORMATION THAT DURING A FOLLOW-UP BY THE TREATING PHYSICIAN, THE PATIENT REPORTED SOME DIZZINESS, LIGHT HEADEDNESS AND WAS MONITORING HIS BLOOD PRESSURE (BP) AT HOME AS THE PATIENT EXPERIENCED HYPOTENSION AFTER THE PROCEDURE. THE BP WAS LOW-IN THE 80S SYSTOLIC SO THE PATIENT WAS RECOMMENDED TO GO TO THE HOSPITAL. HE WAS SEEN IN ER AND NOTED TO HAVE HEMOGLOBIN OF 10 AT THAT TIME. HIS BP REMAINED LOW AND THEREFORE, HE WAS ADMITTED TO THE HOSPITAL AND GIVEN 2 UNITS OF BLOOD. HE WAS DISCHARGED WITHOUT A FOLEY CATHETER. HE WAS ABLE TO VOID WITHOUT SIGNIFICANT HEMATURIA AFTER REMOVAL OF THE FOLEY CATHETER. IN THE LATEST CONVERSATION WITH THE PATIENT , THE PHYSICIAN STATED THAT THE PATIENT IS DOING WELL, HAVING LOTS OF FREQUENCY AND URGENCY FOR URINATION (SIMILAR TO BASELINE). THERE IS NO PAIN OR HEMATURIA. NO REMARKABLE DEVICE MALFUNCTION DURING THE PROCEDURE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168321 OPTILUME BPH CATHETER SYSTEM BPH CATHETER SYSTEM QXB UROTRONIC INC. 1189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R