BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPINCE DISP. AUTO. BIOPSY INSTRUMENT

    MDR report key: 1757243 · Received June 18, 2010

    Report

    Report Number
    1036710-2010-00022
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    April 23, 2010
    Report Date
    June 8, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    KNW
    PMA / PMN Number
    K904987A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 16GA DEVICE WAS USED FOR A LIVER BIOPSY. NO PRODUCT COMPLICATIONS WERE NOTED DURING THE PROCEDURE. THE DEVICE IS UNAVAILABLE FOR INVESTIGATION. NO RELATED IN-PROCESS DEFECTS WERE FOUND. IN THE PAST 24 MONTHS, WE HAVE RECEIVED ONE OTHER REPORT OF A PATIENT HEMATOMA WITH THE BIOPINCE DEVICE. IN THAT CASE, THE PHYSICIAN HAD DIFFICULTY FIRING. FOR THIS REPORT, THE TERRITORY MANAGER HAS MET WITH THE DIRECTOR OF THE HOSPITAL TO ENSURE THE CORRECT TECHNIQUE IS BEING USED WITH THE DEVICE. WITHOUT THE DEVICE TO REVIEW, WE CANNOT CONFIRM THERE WAS A PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, OUR FACILITY RECEIVED THE FOLLOWING REPORT VIA THE MEDWATCH FORM. THE PATIENT UNDERWENT A LIVER BIOPSY WITH THE MICROVASIVE GUN AND HAD NO IMMEDIATE COMPLICATIONS. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH HEMOPHILIA WITH HEMATOMA AS A COMPLICATION OF THE LIVER BIOPSY PERFORMED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPINCE DISP. AUTO. BIOPSY INSTRUMENT BIOPSY INSTRUMENT KNW ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 370-1580-01 00351Z8Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Other