BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY CORE BIOPSY DEVICE

    MDR report key: 1522948 · Received November 5, 2009

    Report

    Report Number
    3005099803-2009-05239
    Event Type
    Injury
    Date Received
    November 5, 2009
    Report Date
    October 12, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE MODEL NUMBER OR LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN.

    Description of Event or Problem · 1

    IN 2009, A BOSTON SCIENTIFIC CORPORATION EMPLOYEE BECAME AWARE OF AN ARTICLE, "OUTPATIENT PERCUTANEOUS RENAL BIOPSY IN ADULT PATIENTS" BY ABDULLA K. AL-KWEISH, ET.AL. PUBLISHED IN FOREIGN JOURNAL OF KIDNEY DISEASES AND TRANSPLANTATION 2007; 18(4) :541-546. THE FOLLOWING INFORMATION WAS DERIVED FROM THIS ARTICLE: AN EASY CORE BIOPSY DEVICE WAS USED DURING A PERCUTANEOUS RENAL BIOPSY OF THE KIDNEY. ACCORDING TO THE ARTICLE, GROSS TRANSIENT HEMATURIA WAS OBSERVED WITHIN SIX HOURS POST PROCEDURE. ATTEMPTS HAVE BEEN UNSUCCESSFUL TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY CORE BIOPSY DEVICE FCG BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other