BEUDAMED
    FDA Adverse Event Death Summary report: N

    16G X 10CM BIOPINCE¿ AUTOMATIC FULL CORE BIOPSY INSTRUMENT

    MDR report key: 8396021 · Received March 6, 2019

    Report

    Report Number
    1625425-2019-00037
    Event Type
    Death
    Date Received
    March 6, 2019
    Date of Event
    February 5, 2019
    Report Date
    February 5, 2019
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    KNW
    PMA / PMN Number
    K904987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED AND NO SIMILAR CONCERNS WERE FOUND. THE RETURNED DEVICE WAS TEST FIRED AND WORKED AS DESIGNED. THE PINCER ON THE NEEDLE SET WAS DAMAGED AND THE DEVICE WOULD BE UNABLE TO ACQUIRE A SPECIMEN. THE EXACT ROOT CAUSE IS UNABLE TO BE DETERMINED. OPTIMUM RETRIEVAL OF TEST SPECIMENS USING THE BIOPINCE DEVICE CAN BE IMPACTED BY DAMAGE TO THE NEEDLE SETS, DAMAGE TO CANNULA TIPS, AS WELL AS PATIENT PHYSIOLOGIC FACTORS. PINCER DAMAGE CAN BE THE RESULT OF HITTING HARD OR CALCIFIED TISSUE, HANDLING OF THE DEVICE DURING USE, SUCH AS TILTING THE NEEDLE TO EXTRACT THE SAMPLE ONTO A SLIDE, OR DURING REINSERTION INTO A COAXIAL NEEDLE. ARGON IS EVALUATING WAYS TO IMPROVE THE FUNCTION OF THE BIOPINCE DEVICE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING AND A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    3 NEEDLES MALFUNCTIONED TO TISSUE RECEIVED AND TIP OF NEEDLE BENT. ONE PATIENT DIED AFTER A REPEAT BIOPSY WITH A DIFFERENT BRAND NEEDLE. THE PATIENT BLED TO DEATH FOLLOWING LIVER BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189484 16G X 10CM BIOPINCE¿ AUTOMATIC FULL CORE BIOPSY INSTRUMENT AUTOMATIC FULL CORE BIOPSY INSTRUMENT KNW ARGON MEDICAL DEVICES INC. 11235852

    Patients

    Seq Age Sex Outcome Treatment
    1 Death