BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTERA

    MDR report key: 2092874 · Received May 11, 2011

    Report

    Report Number
    1833550-2011-00003
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    PROMEX TECHNOLOGIES, LLC
    Product Code
    DYB
    PMA / PMN Number
    K022634
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND NO OTHER COMPLAINTS FOR DIFFICULTY TRACKING OVER WIRE HAVE BEEN RECEIVED. ACCORDING TO OUR PROCEDURES, WE WILL CONTINUE TO MONITOR FOR TRENDING. NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    TRANSJUGULAR LIVER BIOPSY PROCEDURE RESULTED IN BLEEDING REQUIRING SURGERY. THERE WAS DIFFICULTY ADVANCING OVER THE WIRE INTO AND THROUGH HEPATIC VEINS. THE OUTER SHEATH WAS ADVANCED AND BUCKLED. IT WAS THEN STRAIGHTENED. BIOPSY SAMPLE WAS TAKEN. BLEEDING WAS NOTED LATER. AT SURGERY, IT WAS NOT POSSIBLE TO TELL IF THE BLEEDING WAS THE RESULT OF THE NEEDLE PASSES OR THE SHEATH BUCKLING. IT WAS REPORTED THAT OTHER THAN POSSIBLY THE FAILURE TO TRACK OVER THE WIRE, THE OTHER CHALLENGES OF THIS CASE WERE NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTERA INTRODUCER, CATHETER (BIOPSY DEVICE) DYB PROMEX TECHNOLOGIES, LLC TL-19

    Patients

    Seq Age Sex Outcome Treatment
    1 Other