BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 483309 · Received September 11, 2003

    Report

    Report Number
    483309
    Event Type
    Death
    Date Received
    September 11, 2003
    Date of Event
    July 23, 2003
    Report Date
    September 4, 2003
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS ADMITTED IN 2003 WITH ABDOMINAL PAIN. THE PT HAS A PAST HISTORY OF CHRONIC RELAPSING TTP TREATED WITH VINCRISTINE AND PLASMAPHERESIS. CURRENT TREATMENT PLAN WAS FOR INSERTION OF A DIALYSIS CATHETER FOR PLASMAPHERESIS. THE FOLLOWING DAY THE PT UNDERWENT INSERTION OF THIS CATHETER IN INTERVENTIONAL RADIOLOGY WITH SEDATION. THEIR PLATELET COUNT PRE-PROCEDURE WAS 80,000. AS THE MD WAS SUTURING TO CLOSE, THE PT COMPLAINED OF CHEST PAIN. FLUOROSCOPY REVEALED A HEMOTHORAX. THE PT PROCEEDED TO SUFFER A CARDIAC ARREST. CHEST TUBES WERE INSERTED AND DRAINED LARGE AMOUNTS OF BLOOD. ATTEMPTS TO RESUSCITATE WERE UNSUCCESSFUL. THE CAUSE OF THE BLEEDING LEADING TO THE PT'S DEATH HAS NOT BEEN DETERMINED TO DATE. AUTOPSY WAS PERFORMED BY THE COUNTY CORONER BUT NO RESULTS AS TO THE SOURCE OF THE BLEEDING AND DEATH HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * OPTIFLOW CATHETER MSD BARD ACCESS SYSTEMS NA 22DN2878

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death