BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOTECH BIOPINCE

    MDR report key: 3136865 · Received May 22, 2013

    Report

    Report Number
    3136865
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED TO UNDERGO A CT-GUIDED MEDICAL RENAL BIOPSY. THE BIOPSY NEEDLE (BIOPINCE) NEEDLE MISFIRED AND LEFT A PIECE OF METAL "STICKING OUT OF THE NEEDLE." BECAUSE OF THE PROTRUDING METAL, THE NEEDLE WAS "UNABLE TO FIT IN THE GUIDE NEEDLE" AND THEREFORE DID NOT OBTAIN THE NEEDED SPECIMEN. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE BIOPSY PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CT-GUIDED MEDICAL RENAL BIOPSY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226166 ANGIOTECH BIOPINCE INSTRUMENT, BIOPSY KNW MEDICAL DEVICE TECHNOLOGIES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR