BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGON MEDICAL DEVICE'S PAC TRAY/5 6F

    MDR report key: 663572 · Received January 12, 2006

    Report

    Report Number
    1625425-2006-00002
    Event Type
    Death
    Date Received
    January 12, 2006
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 10/2005, A 6F INTRODUCER CATHETER FOR USE WITH A SWAN GANZ CATHETER BROKE OFF IN PT AND LODGED AGAINST VENTRICLE REQUIRING SURGICAL REMOVAL. FRAGMENT PIECE OF CATHETER WAS NOT IDENTIFIED UNTIL 2005. IN 10/2005, UNSUCCESSFUL RETRIEVAL OF BROKEN FRAGMENT IN THE CATH LAB. NEXT DAY SUCCESSFUL RETRIEVAL OF CATHETER IN THE OR REQUIRING STERNOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGON MEDICAL DEVICE'S PAC TRAY/5 6F HEMOSTASIS INTRODUCER DYB ARGON MEDICAL DEVICES INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention