BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 20349091 · Received October 1, 2024

    Report

    Report Number
    3010024164-2024-00005
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    January 10, 2024
    Report Date
    October 1, 2024
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    PMA / PMN Number
    P220023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ABOUT THE EVENT BECAME AVAILABLE IN (B)(6) 2024 WHICH TRIGGERED REPORTABILITY.

    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. 70-YEAR-OLD MALE ENROLLED IN THE GPS REGISTRY ON (B)(6) 2024. PAST MEDICAL HISTORY WAS SIGNIFICANT FOR HYPERTENSION SINCE 1993, PRIOR RENAL DENERVATION PROCEDURE USING AN UNKNOWN DEVICE IN (B)(6) 2011 AND SLEEP APNEA WITH REGULAR CPAP USAGE. SUBJECT WAS NOT ON ANY ANTI-HTN MEDICATIONS AT THE TIME OF CONSENT. ON (B)(6) 2024, THE SUBJECT WAS SUCCESSFULLY TREATED WITH RENAL DENERVATION USING PARADISE ULTRASOUND SYSTEM (URDN). AT THE END OF PROCEDURE AND DURING FINAL RENAL ANGIOGRAM, A DISSECTION WAS NOTED AT SITE OF THE DISTAL ABLATION IN THE LOWER LEFT RENAL ARTERY. UNDER IVUS GUIDANCE, BALLOON INFLATION WITH A 5.5 MM BALLOON WAS PERFORMED; ANTEGRADE BLOOD FLOW IMPROVED AND THE DISSECTION PERSISTED. PER TREATING PROVIDER, THE EVENT RESOLVED ON (B)(6) 2024. THE SUBJECT WAS PRESCRIBED ASPIRIN AND CLOPIDOGREL FOR 4 WEEKS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2024, WITH THE RECOMMENDATION TO HAVE AN AMBULATORY NEPHROLOGY AND HYPERTENSION FOLLOW-UP AND WAS SUGGESTED TO HAVE A CONTROL RENAL ARTERY DOPPLER ULTRASOUND IN 4 WEEKS. ON (B)(6) 2024 PATIENT VISITED TO HIS NEPHROLOGIST AND OBTAINED A RENAL ULTRASOUND WHICH REVEALED VASCULARIZATION WAS PRESERVED AND SYMMETRICAL ON BOTH SIDES. NOTE: ON (B)(6) 2024, ADDITIONAL INFORMATION AND SOURCE DOCUMENTS WERE PROVIDED BY THE SITE. THE EVENT WAS REASSESSED AND IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41355 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC. PRDS-065-02 M3860

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention ASPRIN| CLOPIDOGREL