BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 20519469 · Received October 23, 2024

    Report

    Report Number
    3010024164-2024-00006
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    October 9, 2024
    Report Date
    October 23, 2024
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    PMA / PMN Number
    P220023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES USED WERE NOT RETURNED TO RECOR FOR EVALUATION. INFORMATION PROVIDED DID NOT INDICATE THERE WAS A DEVICE MALFUNCTION. THE REPORTED ISSUE IS A KNOWN AND DOCUMENTED POSSIBLE PATIENT CONDITION OF THE RECOR PROCEDURE (PER THE IFU, POSSIBLE RISKS SECTION) AND NO DEVICE DEFICIENCIES (PACKAGING AND LABELING ISSUES) HAVE BEEN REPORTED. THE EXACT CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONCLUSIVELY DETERMINED.

    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: FEMORAL ARTERY THROMBOSIS. 63-YEAR-OLD FEMALE ENROLLED IN THE GPS REGISTRY ON (B)(6) 2024. PAST MEDICAL HISTORY WAS SIGNIFICANT FOR HYPERTENSION (WITH AN EPISODE OF HYPERTENSIVE CRISIS ON (B)(6) 2024), HYPERLIPIDEMIA, TYPE-II DIABETES, AND CHRONIC KIDNEY DISEASE, WITH MOST RECENT EGRF VALUE OF 45.32 ML/MIN/1.73 M2, ATHEROSCLEROSIS OF THE ABDOMINAL VESSELS WITHOUT RELEVANT STENOSIS, PROLACTINOMA, DEPRESSION AND PANIC ATTACKS, STRUMA NODOSA, CALCIFICATION OF AORTA, HYPERURICEMIA AND VITAMIN D DEFICIENCY. SUBJECT WAS ON 6 ANTI-HTN MEDICATIONS AT THE TIME OF CONSENT. ON (B)(6) 2024, THE SUBJECT UNDERWENT RENAL DENERVATION PROCEDURE, AND THE PROCEDURE WAS UNEVENTFUL. ON (B)(6) 2024, 20 DAYS POST PROCEDURE, THE SUBJECT WAS ADMITTED TO THE HOSPITAL WITH SENSORY DISORDER AND COLDNESS ON THE RIGHT LEG. WITH A SUSPICION OF LEG ISCHEMIA, A CT SCAN OF PELVIS-LEG VESSELS WAS PERFORMED, WHICH NOTED A SHORT-RANGE OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY. MODERATE SCLEROSIS WAS ALSO NOTED IN BOTH SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES, WITHOUT RELEVANT STENOSIS. HOWEVER, PERFUSION IN POPLITEAL ARTERY WAS INTACT. THE SUBJECT WAS STARTED ON PROSTAVASIN THERAPY (40 MICROGRAMS). ON (B)(6)2024, THROMBOENDARTERECTOMY OF THE THROMBUS WAS PERFORMED. THE SUBJECT'S CONDITION WAS IMPROVED AND WAS DISCHARGED UNDER STABLE CONDITIONS ON (B)(6) 2024. THE EVENT WAS RESOLVED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374295 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC. PRDS-065-02 M4310

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Hospitalization A.S.S.| AMLODIPINE.| CANDESARTAN.| CARVEDILOL.| HYDROCHLOROTHIAZIDE.| INSULIN LISPRO.| L-THYROXIN.| MOXONIDIN.| PROSTAVASIN.| SPIRONOLOACTONE.