BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 19996092 · Received August 15, 2024

    Report

    Report Number
    3010024164-2024-00003
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 15, 2024
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    PMA / PMN Number
    P220023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    NO CORRELATION OF THE EVENT WITH DEVICE WAS FOUND. THERE IS NO INDICATION OF ANY FAILURE OF THE DEVICE. IN ADDITION, THERE IS NO INDICATION OF ANY MISUSE OF THE DEVICE. EVENT: OXYGEN SATURATION DECREASED. A PATIENT UNDERWENT ULTRASOUND RENAL DENERVATION PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, AFTER THE SECOND ULTRASOUND EMISSION, THE PATIENT'S OXYGEN SATURATION DROPPED. AFTER 3-5 MINUTES OF REANIMATION MEASURES, THE PATIENT'S CONDITION IMPROVED WITH NO FURTHER SEQUELAE. AFTER 6 MINUTES OF INTERRUPTION, RENAL DENERVATION PROCEDURE WAS CONTINUED. PROCEDURE COMPLETED SUCCESSFULLY AND THE PATIENT WAS STABLE AT THE END OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985433 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER, RENAL DENERVATION QYI RECOR MEDICAL, INC. PRDS-064-02 M4334

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other