BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 20087838 · Received August 28, 2024

    Report

    Report Number
    3010024164-2024-00004
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    August 15, 2024
    Report Date
    August 27, 2024
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    PMA / PMN Number
    P220023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: RENAL ARTERY THROMBOSIS. A 37-YEAR-OLD FEMALE PATIENT WITH PAST MEDICAL HISTORY OF HYPERTENSIVE CRISIS, POLYCYSTIC KIDNEY DISEASE AND ALLERGIES TO NUMEROUS ANTI-HYPERTENSIVES AND MANY OTHER MEDICATIONS. THE PATIENT UNDERWENT RENAL DENERVATION PROCEDURE ON (B)(6) 2024. SHE WAS GIVEN 5000U OF HEPARIN. AFTER SUCCESSFUL COMPLETION OF URDN IN BOTH THE LEFT (3 ABLATIONS) AND RIGHT (2 ABLATIONS) RENAL ARTERIES, THE PHYSICIAN PERFORMED FINAL SELECTIVE ANGIOGRAMS AND NOTED A CLOT IN THE RIGHT RENAL ARTERY. THROMBUS WAS SUCCESSFULLY TREATED WITH PENUMBRA 6FR CATRX SYSTEM, 6MG TPA IN RRA AND 2000U HEPARIN. PATIENT WAS INPATIENT HOSPITALIZED WHILE TREATED AND DISCHARGED ON (B)(6) 2024. PHYSICIAN ASSESSED THE THROMBOSIS AS NOT RELATED TO PARADISE DEVICE AND PROCEDURE, AND ATTRIBUTED THE OCCURRENCE OF EVENT TO NOT GIVING ENOUGH ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573615 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER, RENAL DENERVATION QYI RECOR MEDICAL, INC. PRDS-065-02 M4052

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention HEPARIN 2000 UNITS| PENUMBRA 6FR CATRX SYSTEM| TISSUE PLASMINOGEN ACTIVATOR (TPA) 6MG