BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILUME BPH CATHETER SYSTEM

    MDR report key: 19894575 · Received August 2, 2024

    Report

    Report Number
    3015228875-2024-00002
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    February 23, 2024
    Report Date
    August 2, 2024
    Manufacturer
    UROTRONIC INC.
    Product Code
    QXB
    PMA / PMN Number
    P220029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MDR REPORT IS OUTSIDE OF THE 30-DAY REPORTING REQUIREMENT BECAUSE THE FIRM HAS DIFFICULTY SUBMITTING REPORT USING E-SUBMITTER. DUE TO COMPANY AQUISITION, EMAIL ADDRESSES WERE CHANGED INCLUDING PREVIOUS EMAIL LINKED TO FDA E-SUBMITTER AND WEBTRADER ACCOUNTS. ANY REQUIRED FIELDS THAT ARE BLANK ARE DUE TO INFORMATION THAT IS CURRENTLY UNKNOWN OR UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OPTILUME BPH CATHETER SYSTEM WAS USED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA. THE PROCEDURE WAS COMPLETED WITH NO INCIDENT. THE FOLEY CATHETER WAS REMOVED 2-3 DAYS AFTER THE PROCEDURE AND THE PATIENT WAS ABLE TO VOID SUCCESSFULLY WITH CLEAR URINE. APPROXIMATELY 3-6 WEEKS AFTER THE PROCEDURE, THE PATIENT INFORMED THE TREATING PHYSICIAN OF A HEMATURIA EVENT NECESSITATING CYSTOSCOPIC INTERVENTION OF CLOT EVACUATION AND FULGARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400173 OPTILUME BPH CATHETER SYSTEM BPH CATHETER SYSTEM QXB UROTRONIC INC. 1189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention