BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 23472497 · Received November 4, 2025

    Report

    Report Number
    3010024164-2025-00003
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 4, 2025
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    UDI-DI
    00810008950012
    PMA / PMN Number
    P220023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THERE IS NO INDICATION OF ANY FAILURE OF THE DEVICE. IN ADDITION, THERE IS NO INDICATION OF ANY MISUSE OF THE DEVICE. EVENT: RENAL ARTERY DISSECTION. EVENT DESCRIPTION: TWO DISSECTIONS WERE IDENTIFIED IN DISTAL SEGMENT OF LEFT RENAL ARTERY. THE DISTAL SEGMENT WAS TREATED SUCCESSFULLY BY STENTING. POST-PROCEDURE VITALS WERE STABLE, AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2693478 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC. M4707 00810008950012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention 7F CORTIS RDC CATHETER| PHILLIPS VOLCANO IVUS| TERUMO RUNTHROUGH WIRE