BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIO PINCE ULTRA 18G 10CM

    MDR report key: 15815156 · Received November 17, 2022

    Report

    Report Number
    MW5113330
    Event Type
    Death
    Date Received
    November 17, 2022
    Date of Event
    October 27, 2022
    Report Date
    November 15, 2022
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WENT TO INTERVENTIONAL RADIOLOGY FOR A LIVER BIOPSY USING THE BIOPIN ULTRA 18G. POST-PROCEDURE, THE PATIENT DEVELOPED RESPIRATORY DISTRESS PROMPTING A CHEST ULTRASOUND WHICH SHOWED BLEEDING IN THE RIGHT CHEST. PIGTAIL PLACED FOR DRAINAGE; HOWEVER, BLEEDING PERSISTED AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR CHEST EXPLORATION. PATIENT FOUND TO HAVE A PUNCTURE SITE IN THE RIGHT LOWER LOBE WITH SIGNIFICANT AMOUNT OF BLOOD LOSS WITHIN THE CHEST. IT'S BELIEVED THAT THE DEVICE MISFIRED AT A LONGER DISTANCE THAN WHAT WAS SET. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2786898 BIO PINCE ULTRA 18G 10CM INSTRUMENT, BIOPSY KNW ARGON MEDICAL DEVICES INC. 11435288

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Male Death