BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPINCE FULL CORE BIOPSY INSTRUMENT

    MDR report key: 1900549 · Received October 29, 2010

    Report

    Report Number
    1036710-2010-00035
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ANGIOTECH, MED DEVICE TECHNOLOGIES
    Product Code
    KNW
    PMA / PMN Number
    K904987A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED BIOPINCE DEVICE, AND THREE STERILE SAMPLES FROM THE REPORTED LOT NUMBER WERE RETURNED FOR INVESTIGATION. THE PINCER IS BENT AND CURLED UNDER. THE THREE STERILE DEVICES RETURNED FROM THE SAME LOT NUMBER WERE TEST FIRED INTO BEEF KIDNEY WITH NO DEFECTS REPORTED. THE DEFECT WAS DUPLICATED BY FIRING THE DEVICE INTO THE STYROFOAM. THE STYROFOAM PREVENTED THE PINCER FROM DIVING INTO THE PINCER WINDOW AS INTENDED; IT ALSO PREVENTED THE PINCER FROM MOVING FURTHER ON THE CANNULA AND THUS CAUSING IT TO CURL UNDER. AS IN THE COMPLAINT, A SAMPLE WAS STILL COLLECTED. THIS WOULD REPLICATE THE EFFECT OF THE DEVICE HITTING HARD TISSUE/CALCIFIED LESION PREVENTING THE PINCER FROM FUNCTIONING AS INTENDED DURING THE PROCEDURE. NO DEFECTS OR DEVIATIONS NOTED ON BATCH RECORD. WE WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    DR (B)(6) WAS PERFORMING A LIVER BIOPSY USING BIOPINCE BIOPSY DEVICE ON (B)(6), 2010. THE PT COMPLAINED OF "EXCRUCIATING PAIN" AND HE WITHDREW THE DEVICE. HE NOTICED A LARGE "BURR" ON THE SIDE OF THE DISTAL END OF THE CANNULA. HE DID GET A FULL INTACT SAMPLE, BUT REFUSED TO USE ANY FURTHER PRODUCT FROM THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPINCE FULL CORE BIOPSY INSTRUMENT FULL CORE BIOPSY INSTRUMENT KNW ANGIOTECH, MED DEVICE TECHNOLOGIES 370-1080-01 021422AR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other