BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 24754221 · Received April 1, 2026

    Report

    Report Number
    3010024164-2026-00002
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 31, 2026
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    UDI-DI
    00810008950036
    PMA / PMN Number
    P220023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    EVENT: RENAL ARTERY DISSECTION. EVENT DESCRIPTION: 40 YR OLD MALE PATIENT UNDERWENT RENAL DENERVATION PROCEDURE ON (B)(6) 2026. AFTER SONICATION OF THE LEFT MAIN RENAL ARTERY, A DISSECTION WAS NOTED IN ONE OF THE BRANCHES OF LEFT MAIN RENAL ARTERY. IT WAS CONFIRMED THAT THE DISSECTION WAS CAUSED DUE TO INADVERTENT USE OF AN OVERSIZED BALLOON (7 MM BALLOON IN A 4.8 MM VESSEL) BECAUSE OF INACCURATE MEASUREMENT OF THE VESSEL DIAMETER FROM PRE-PROCEDURAL CT SCAN. TO MANAGE THE DISSECTION, AN ONYX BALLOON (MEDTRONIC) WAS INFLATED AT THE DISSECTION SITE FOR 3 MINS TO FACILITATE THE REAPPOSITION OF THE DISSECTION FLAP AND TO SUPPORT SPONTANEOUS SEALING OF THE DISSECTION. THE EVENT RESOLVED, PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON (B)(6) 2025 AFTER 24 HOURS OF OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817755 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC. PRDS-067-02 M4901 00810008950036

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention