BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN¿ COACCESS¿

    MDR report key: 6835969 · Received August 31, 2017

    Report

    Report Number
    2134265-2017-08651
    Event Type
    Injury
    Date Received
    August 31, 2017
    Report Date
    August 7, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: BALAGEAS ET AL. (2013). EUROPEAN JOURNAL OF RADIOLOGY. TEN-YEAR EXPERIENCE OF PERCUTANEOUS IMAGE-GUIDED RADIOFREQUENCY ABLATION OF MALIGNANT RENAL TUMORS IN HIGH-RISK PATIENTS. EUR RADIOL, 23, 1925-1932. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENTS EXPERIENCED COMPLICATIONS POST RADIOFREQUENCY ABLATION (RFA) PROCEDURES. IMMEDIATE COMPLICATIONS OCCURRED WITHIN 3 DAYS PERI-RENAL HEMATOMA, ADRENAL HEMATOMA, RENAL INFARCTION, PNEUMOTHORAX AND LIVER THERMAL INJURY. EARLY COMPLICATIONS OCCURRED WITHIN LESS THEN 7 DAYS ARTERIAL HYPERTENSION, ARTERIAL HYPOTENSION, ACUTE PARANOID REACTION, AEUROLOGICAL PAIN, INFLAMMATORY REACTION OF PANCREATIC CYST, MINIMAL FISTULA WITHOUT URINOMA, CUTE KIDNEY FAILURE WITH TRANSITORY DIALYSIS, HAEMORRHAGING AND TRANSFUSION, CUTANEOUS FISTULA PLUS URINOMA PLUS INFECTION , DUODENAL PERFORATION PLUS ABSCESS. LATE COMPLICATIONS OCCURRED IN GREATER THAN 7 DAYS, LIVER HEMATOMA AT 2 MONTHS, URETERAL STENOSIS PLUS HEMATOMA INFECTION, URETERAL STENOSIS PLUS CUTANEOUS FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614002 LEVEEN¿ COACCESS¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001262230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other