BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILUME BPH CATHETER SYSTEM

    MDR report key: 19850997 · Received July 29, 2024

    Report

    Report Number
    3015228875-2024-00001
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    April 16, 2024
    Report Date
    July 25, 2024
    Manufacturer
    UROTRONIC INC.
    Product Code
    QXB
    PMA / PMN Number
    P220029
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 HAD DIFFICULTY SUBMITTING REPORT USING E-SUBMITTER. DUE TO COMPANY ACQUISITION, EMAIL ADDRESSES WHERE CHANGED INCLUDING PREVIOUS EMAIL LINKED TO FDA E-SUBMITTER AND WEBTRADER ACCOUNTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ON APRIL 17, 2024, UROTRONIC WAS MADE AWARE OF A PATIENT WHO RECEIVED BPH TREATMENT PROCEDURE ON (B)(6) 2024 USING THE OPTILUME BPH CATHETER SYSTEM. THE PATIENT EXPERIENCED PERSISTENT HEMATURIA AND WAS ADMITTED IN THE HOSPITAL, WHERE HE UNDERWENT CONTINOUS BLADDER IRRIGATION AND TXA ADMINSTRATION. THE PATIENT UNDERWENT CYSTOSCOPIC CLOT EVACUATION AND CAUTERIZATION FOR CONTINUED BLEEDING. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH CLEAR URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950986 OPTILUME BPH CATHETER SYSTEM BPH CATHETER SYSTEM QXB UROTRONIC INC. 1189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H