BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABLATION CATHETER, RENAL DENERVATION

    MDR report key: 19044909 · Received April 4, 2024

    Report

    Report Number
    3010024164-2024-00001
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    January 18, 2024
    Report Date
    March 13, 2024
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    PMA / PMN Number
    P220023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP TO INCLUDE MANUFACTURER INFORMATION IN SECTION D3. THIS SECTION WAS INADVERTANTLY LEFT BLANK IN THE INITIAL SUBMISSION.

    Additional Manufacturer Narrative · 0

    THIS IS OUR FIRST ELECTRONIC MDR SUBMISSION AND THE REPORT WAS DELAYED DUE TO THE SIGNUP PROCESS. WE MAILED A HARD COPY TO FDA ON MARCH 13, 2024 WHICH WAS REJECTED.

    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: POST PROCEDURAL HEMATOMA. A 64-YEAR-OLD FEMALE PATIENT WAS SUCCESSFULLY TREATED WITH URDN PROCEDURE ON BILATERAL RENAL ARTERIES ON (B)(6) 2024. ON (B)(6) 2024, THREE DAYS FOLLOWING THE PROCEDURE, PATIENT HAD LOWER ABDOMINAL PAIN. CT OF THE ABDOMEN AND PELVIS WAS PERFORMED WHICH REVEALED INTRAPARENCHYMAL AND SUBCAPSULAR HEMATOMAS OF THE RIGHT KIDNEY AND POSTERIOR PARARENAL FASCIA WITHOUT EVIDENCE OF ACTIVE BLEEDING. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. SUPPORTIVE TREATMENT WAS GIVEN. ON (B)(6) 2024, PATIENT'S CONDITION WAS IMPROVED AND PATIENT WAS DISCHARGED UNDER STABLE CONDITION.

    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: POST PROCEDURAL HEMATOMA. A 64-YEAR-OLD FEMALE PATIENT WAS SUCCESSFULLY TREATED WITH URDN PROCEDURE ON BILATERAL RENAL ARTERIES ON (B)(6) 2024. ON (B)(6) 2024, THREE DAYS FOLLOWING THE PROCEDURE, PATIENT HAD LOWER ABDOMINAL PAIN. CT OF THE ABDOMEN AND PELVIS WAS PERFORMED WHICH REVEALED INTRAPARENCHYMAL AND SUBCAPSULAR HEMATOMAS OF THE RIGHT KIDNEY AND POSTERIOR PARARENAL FASCIA WITHOUT EVIDENCE OF ACTIVE BLEEDING. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. SUPPORTIVE TREATMENT WAS GIVEN. ON (B)(6) 2024, PATIENT'S CONDITION WAS IMPROVED AND PATIENT WAS DISCHARGED UNDER STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86630 ABLATION CATHETER, RENAL DENERVATION QYI RECOR MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization AAS| AAS| ALDACTONE| ALDACTONE| ATENOLOL| ATENOLOL| ATOZET| ATOZET| CAPENON HCT| CAPENON HCT| CARDURAN| CARDURAN| CLOPIDOGREL| CLOPIDOGREL| HYDRALAZINE| HYDRALAZINE| RECOR PARADISE RENAL DENERVATION SYSTEM| RECOR PARADISE RENAL DENERVATION SYSTEM| TOUJEO| TOUJEO