BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 23059671 · Received September 15, 2025

    Report

    Report Number
    3010024164-2025-00002
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    August 27, 2025
    Report Date
    September 15, 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: SUBJECT UNDERWENT PROCEDURE ON (B)(6) 2025. AFTER COMPLETING TREATMENT IN THE LEFT MAIN RENAL ARTERY, CINE NOTED A LESION WHICH WAS INITIALLY SUSPECTED TO BE SPASM AS PER PHYSICIAN. RIGHT RENAL ARTERY WAS TREATED WITH NO ISSUES. AFTER COMPLETING BILATERAL TREATMENT, ANGIOGRAM NOTED A FLOW-LIMITING DISSECTION IN THE LEFT RENAL ARTERY (LRA) AT THE MOST DISTAL LOCATION WHICH WAS TREATED WITH BALLOON ANGIOPLASTY AND STENTING. POST-PROCEDURE VITALS WERE STABLE, AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. AS PER PHYSICIAN, UNIQUE ANATOMY WITH RENAL ARTERY TORTUOSITY WHICH MAY CAUSE POTENTIAL STRAIGHTENING AND/OR DISSECTION FROM ANY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659739 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC. M4347 00810008950012

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention MDT IMA 7FR GUIDE CATHETER| SCION BLUE WIRE, 0.014 INTRAVASCULAR ULTRASOUND