BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 20973164 · Received December 18, 2024

    Report

    Report Number
    3010024164-2024-00010
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    December 4, 2024
    Report Date
    December 18, 2024
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    PMA / PMN Number
    P220023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES USED IN THIS PROCEDURE WERE NOT RETURNED TO RECOR FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONAL INFORMATION ON DEVICES USED: MODEL: PRDS-067-02 LOT: M4180, SERIAL NUMBER: (B)(6). MODEL: PRDS-CT-02 LOT: 026736. MODEL: PRDS-USG-2X SERIAL NUMBER: (B)(6).

    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: ASYSTOLE 59-YEAR-OLD MALE ENROLLED IN RADIANCE DUO ON (B)(6) 2024. PAST MEDICAL HISTORY WAS SIGNIFICANT FOR DYSLIPIDEMIA, COVID-19, HYPERURICAEMIA, LATE EFFECT OF FRACTURE OF KNEE, ASTHMA IN CHILDHOOD AND INSOMNIA. SUBJECT WAS ON TWO ANTIHYPERTENSIVE MEDICATIONS AT THE TIME OF CONSENT. SUBJECT WAS RANDOMIZED ON (B)(6) 2024, AND CROSS OVER PROCEDURE WAS PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, CLINICALLY NON-SIGNIFICANT BRADYCARDIA WAS NOTED AFTER STARTING DEXTOMETHOMIDINE AT A FLOW RATE OF 10 ML/H. AS THE SUBJECT WAS NOT SUFFICIENTLY SEDATED, 3 ML OF DEXTOMETHOMIDINE WAS ADMINISTERED INTRAVENOUSLY. WHILE DELIVERING THE SECOND SONICATION IN THE LEFT RENAL ARTERY, ASYSTOLE (CARDIAC ARREST) WAS NOTED FOR 12 SECONDS AND CPR WAS PERFORMED SUCCESSFULLY WITH RESUMPTION OF HEARTBEAT. ATROPINE SULFATE WAS ADMINISTERED TWICE AND THE TREATMENT FOR LEFT RENAL ARTERY WAS DISCONTINUED. AFTER THE HEART BEAT RESUMED, THE DEXTOMETHOMIDINE FLOW RATE WAS REDUCED TO 5 ML/H, BUT WAS THEN DISCONTINUED. AFTER SUBJECT'S VITALS STABILIZED, TREATMENT OF RIGHT RENAL ARTERY WAS INITIATED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NOTE: AS PER PHYSICIAN, THE SUBJECT HAD NO HISTORY OF RELEVANT CARDIAC DISEASE AND THE CAUSE OF THIS EVENT IS BELIEVED TO BE BRADYCARDIA CAUSED BY THE INTERACTIONS OF THE ABLATION AND SEDATIVE, WHICH THEN LED TO CARDIAC ARREST (ASYSTOLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083882 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC. PRDS-066-02 M4179

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| L ATROPINE SULPHATE| CARDIOPULMONARY RESUSCITATION (CPR)| DEXTOMETHOMIDINE