BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILUME URETHRAL DRUG COATED BALLOON

    MDR report key: 21605245 · Received March 14, 2025

    Report

    Report Number
    21605245
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 24, 2025
    Report Date
    February 27, 2025
    Manufacturer
    UROTRONIC, INC.
    Product Code
    QRH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE, THE OPTILUME IS A URETHRAL DRUG-COATED BALLOON WAS PLACED IN THE PATIENT, AND WHILE INFLATING THE BALLOON, THERE WAS A "POP". THE BALLOON WAS REMOVED AND INSPECTED BY THE SURGEON AND MANUFACTURER REPRESENTATIVE. IT APPEARS ALL PIECES WERE REMOVED FROM THE PATIENT, AND A NEW BALLOON WAS USED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958167 OPTILUME URETHRAL DRUG COATED BALLOON CATHETER, BALLOON, URETHRAL, DRUG-COATED QRH UROTRONIC, INC. 1110 30615

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male