BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAP BIOPSY DEVICE

    MDR report key: 1525188 · Received November 9, 2009

    Report

    Report Number
    3005099803-2009-05294
    Event Type
    Injury
    Date Received
    November 9, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE MODEL NUMBER OR LOT NUMBER; THEREFORE, THE DEVICE MFR AND EXPIRATION DATES ARE UNK.

    Description of Event or Problem · 1

    ON OCT 12, 2009, A BOSTON SCIENTIFIC CORP EMPLOYEE BECAME AWARE OF AN ARTICLE, "ACCURACY OF PERCUTANEOUS CORE BIOPSY IN MANAGEMENT OF SMALL RENAL MASSES" BY ROU WANG, ET.AL. PUBLISHED IN UROLOGY 73: 586-590, 2009. THE FOLLOWING INFO WAS DERIVED FROM THIS ARTICLE: AN ASAP BIOPSY DEVICE WAS USED DURING A PERCUTANEOUS CORE BIOPSY OF THE RENAL MASS. ACCORDING TO THE ARTICLE, THE "PT WAS NOTED TO BE HYPOTENSIVE AFTER THE PROCEDURE, AND WAS RESUSCITATED WITH FLUIDS, BUT REQUIRED NO FURTHER INTERVENTION." ATTEMPTS HAVE BEEN UNSUCCESSFUL TO OBTAIN ADDITIONAL INFO. THIS REPORT IS FOR ONE OF TWO DEVICES. REFER TO REPORT # 3005099803-2009-05291 FOR A DESCRIPTION OF THE SECOND DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R