BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAL ACCESS AND BIOPSY SET

    MDR report key: 292273 · Received August 28, 2000

    Report

    Report Number
    1820334-2000-00066
    Event Type
    Death
    Date Received
    August 28, 2000
    Date of Event
    July 29, 2000
    Report Date
    August 3, 2000
    Manufacturer
    COOK INC
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A TRANSJUGULAR RENAL BIOPSY WAS BEING PERFORMED. THE PT'S RIGHT KIDNEY WAS SEEN TO BE POSTEROMEDIALLY DISPLACED ON THEIR MRI. DESPITE AIMING WHERE THE MRI WOULD SUGGEST A SAFE BIOPSY COULD BE PERFORMED, THE PHYSICIAN SUSPECTS THE PT'S CAPSULE WAS PERFORATED. AT THE END OF THE PROCEDURE, PHYSICAL EXAM REVEALED A RIGHT FLANK SWELLING. ULTRASOUND SHOWED A HETEROGENOUS RETROPERITONEAL MASS SURROUNDING THE KIDNEY, SUSPICIOUS FOR A HEMORRHAGE. AN ANGIOGRAM SHOWED KIDNEY WAS BLEEDING. THE KIDNEY WAS EMBOLIZED, BUT DURING THE PROCEDURE, THE PT BECAME SEVERELY BRADYCARDIAC AND HYPOTENSIVE, AND REQUIRED 5 MINUTES OF CPR AND PRESSORS, BUT REGAINED SINUS RHYTHM. PT WAS TRANSFERRED TO EICU AND DIED 2 1/2 HOURS LATER DESPITE MASSIVE TRANSFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL ACCESS AND BIOPSY SET SPECIAL SET FCG COOK INC NA P680227

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death