BEUDAMED
    FDA Adverse Event Death Summary report: N

    COAXIAL TEMNO

    MDR report key: 866864 · Received June 15, 2007

    Report

    Report Number
    866864
    Event Type
    Death
    Date Received
    June 15, 2007
    Date of Event
    June 7, 2007
    Report Date
    June 7, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BEEN DIALYZED AND UNDERGONE A THORACENTESIS EARLIER IN THE DAY. HE WAS IN THE PROCESS OF UNDERGOING A NEEDLE BIOPSY OF THE LIVER FOR SUSPECTED METASTATIC LIVER DISEASE. THE FIRST NEEDLE PASS FAILED TO OBTAIN TISSUE AND IT WAS NOTED THAT THE BIOPSY NEEDLE HAD BROKEN, LEAVING THE DISTAL PORTION OF THE NEEDLE WITHIN THE LIVER. THE NEEDLE WAS AT A RIGHT ANGLE TO THE PLANE OF THE BIOPSY. A SECOND PASS USING A NEW NEEDLE WAS UNDERTAKEN AND ADEQUATE BIOPSY CORES OBTAINED. SHORTLY AFTER THE BIOPSY PROCEDURE, THE PATIENT DEVELOPED EVIDENCE OF INTERNAL BLEEDING. HIS HEMOGLOBIN DROPPED FROM 11.6 GM TO 5.9 GM, HE BECAME HYPOTENSIVE AND ARRESTED.AUTOPSY SUMMARY: IN THE OPINION OF THE PATHOLOGIST, THE PATIENT DIED FROM INTRA-ABDOMINAL BLEEDING FOLLOWING THE NEEDLE BIOPSY OF THE LIVER. DESPITE HAVING A NORMAL PRO TIME OF 11.4 SECONDS, HE PROBABLY LACKED NORMAL CLOTTING CAPABILITY DUE TO CHRONIC RENAL FAILURE AND TO EXTENSIVE REPLACEMENT OF HIS LIVER BY A POORLY DIFFERENTIATED ADENOCARCINOMA HAVING FEATURES CONSISTENT WITH A POORLY DIFFERENTIATED CHOLOANGIOCARCINOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAXIAL TEMNO NEEDLE BIOPSY KNW CARDINAL HEALTH CT2015 D05081320

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death DIALYSIS