BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE® ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 20032418 · Received August 22, 2024

    Report

    Report Number
    3010024164-2024-00002
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 21, 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

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND THEREFORE UNAVAILABLE FOR INVESTIGATION. BASED ON THE INFORMATION KNOWN, THE EVENT WAS UNRELATED TO A DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    THERE IS NO INDICATION OF ANY FAILURE OF THE DEVICE. PATIENT DID NOT HAVE A PAST MEDICAL HISTORY OF HYPERTENSION. DEVICE WAS USED OUTSIDE CURRENT LABEL INDICATIONS. EVENT: RENAL ARTERY DISSECTION. 24 YEAR OLD FEMALE WITH A PAST MEDICAL HISTORY OF MULTIPLE COMORBIDITIES INCLUDING NUTCRACKER SYNDROME AND ORTHOSTATIC HYPOTENSION UNDERWENT UNILATERAL RENAL DENERVATION OF THE LEFT MAIN RENAL ARTERY ON (B)(6) 2024. THE INTENTION OF THE TREATMENT TEAM WAS TO RELIEVE PAIN AND PELVIC CONGESTION AS A LAST RESORT BEFORE KIDNEY REMOVAL; THESE ARE OUTSIDE CURRENT LABEL INDICATIONS. THREE EMISSIONS WERE SUCCESSFULLY PLACED IN THE LEFT RENAL ARTERY. AFTER THE PARADISE DEVICE WAS REMOVED AND DURING THE FINAL ANGIOGRAM, A NON-FLOW LIMITING DISSECTION WAS NOTED NEAR THE SITE OF THE 2ND SONICATION. IN ADDITION, VASOSPASM WAS OBSERVED AND NITRO WAS GIVEN. PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION, DISCHARGED, AND IS DOING WELL PER TREATING PHYSICIAN. PATIENT WAS PRESCRIBED DUAL ANTI-PLATELET THERAPY FOR 1 MONTH, FOLLOW-UP CT ANGIOGRAM ON POST OP DAY 1 SHOWED PATENT LEFT MAIN RENAL AND ACCESSORIES WITHOUT ANY SIGNIFICANT POSTPROCEDURAL CHANGES. FOLLOW-UP IS SCHEDULED IN A MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968375 PARADISE® ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER, RENAL DENERVATION QYI RECOR MEDICAL, INC. PRDS-065-02 M4032

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Hospitalization DUAL ANTI-PLATELET THERAPY| NITRO