BEUDAMED
    FDA Adverse Event Death Summary report: N

    STARTER GUIDEWIRE

    MDR report key: 535725 · Received July 21, 2004

    Report

    Report Number
    6000136-2004-00002
    Event Type
    Death
    Date Received
    July 21, 2004
    Date of Event
    June 17, 2004
    Report Date
    June 22, 2004
    Manufacturer
    LAKE REGION MFG, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEPATIC BIOPSY PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. TRANSJUGULAR ACCESS WAS OBTAINED, BUT FOLLOWING THE BIOPSY, SLIGHT RESISTANCE WAS MET DURING REMOVAL OF THE STARTER GUIDEWIRE THROUGH THE COOK GUIDE CATHETER. THE GUIDEWIRE FRACTURED AND A SEGMENT MIGRATED TO THE PULMONARY ARTERY. DURING RETRIEVAL ATTEMPTS, THE PHYSICIAN PERFORATED THE PERICARDIUM RESULTING IN A PERICARDIAL EFFUSION AND RHYTHM DISORDERS WHICH PROGRESSED TO CARDIAC ARREST AND SUBSEQUENT PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARTER GUIDEWIRE PTA GUIDE WIRE DQX LAKE REGION MFG, INC. NA 01739424

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death