BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 20563648 · Received October 29, 2024

    Report

    Report Number
    3010024164-2024-00007
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    September 15, 2024
    Report Date
    October 29, 2024
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    UDI-DI
    00810008950012
    PMA / PMN Number
    P220023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES USED IN THIS PROCEDURE WERE NOT RETURNED TO RECOR FOR EVALUATION. HOWEVER, INFORMATION THAT WAS PROVIDED DOES NOT INDICATE THAT THERE WAS A MALFUNCTION OR ABNORMALITY WITH THE EQUIPMENT. ADDITIONAL DEVICES USED: PARADISE CARTRIDGE REF - PRDS- CT-02 LOT - 025883 EXP - 2025-09-11. CONNECTION CABLE REF - PRDS- CC-02 LOT - M4169 EXP - 2026-01-15.

    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: HYPERTENSIVE CRISIS 46-YEAR-OLD FEMALE ENROLLED IN THE GPS REGISTRY ON 03 SEP 2024. PAST MEDICAL HISTORY WAS SIGNIFICANT FOR HYPERTENSION SINCE 2014 (LAST EPISODE OF HYPERTENSIVE CRISIS ON 10 OCT 2023), TYPE-II DIABETES, STROKE ON (B)(6) 2024 AND COILING OF ANTERIOR COMMUNICATING ARTERY ANEURYSM. SUBJECT WAS ON 4 ANTI-HTN MEDICATIONS (BISOPROLOL 5 MG, TRANDATE 200MG, SPIRONOLACTONE 25MG AND FELODIPINE 10MG) AT THE TIME OF CONSENT. ON (B)(6) 2024, THE SUBJECT UNDERWENT RENAL DENERVATION PROCEDURE, AND THE PROCEDURE WAS UNEVENTFUL. ON (B)(6) 2024, 03 DAYS POST-PROCEDURE, SUBJECT PRESENTED TO HOSPITAL WITH COMPLAINTS OF THUNDERCLAP OCCIPITAL HEADACHE AND LEFT EYE BLURRING, RESULTING IN HOSPITALIZATION. ON THE SAME DAY, CT HEAD AND CT ANGIOGRAM WERE PERFORMED, WHICH NOTED A COMPLETE OCCLUSION OF PREVIOUSLY COILED ANTERIOR COMMUNICATING ARTERY ANEURYSM. NO SIGNS OF ANEURYSMAL SUBARACHNOID HEMORRHAGE, ACUTE ISCHEMIC INFARCTION, STROKE OR HYDROCEPHALUS WERE NOTED. ON (B)(6) 2024, A LUMBAR PUNCTURE WAS PERFORMED WHICH SHOWED NO EVIDENCE OF SUBARACHNOID HEMORRHAGE. THE HEADACHE WAS ATTRIBUTED TO HIGH BLOOD PRESSURE. BP MEASUREMENTS AT THE TIME OF THE EVENT ARE NOT AVAILABLE. DOSE OF ANTI-HYPERTENSIVES MEDICATIONS WERE UNCHANGED. THE SUBJECT'S CONDITION WAS IMPROVED AND WAS DISCHARGED UNDER STABLE CONDITION ON (B)(6) 2024. THE EVENT WAS RESOLVED ON 18 SEP 2024. ON 16 OCT 2024, SOURCE DOCUMENT WAS PROVIDED BY THE SITE. THE EVENT WAS REASSESSED ON 17 OCT 2024 AND REPORTABILITY DECISION WAS MADE ON SAME DAY BASED ON THE NEW INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042969 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC. PRDS-065-02 M4310 00810008950012

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Hospitalization AMITRYPTYLINE| BISOPROLOL| EMPAGLIFLOZIN| FELODIPINE| FENTANYL| LINAGLIPTIN| METFORMIN| MIDAZOLAM| SPIRONOLACTONE| TRANDATE