BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGON

    MDR report key: 2061325 · Received April 12, 2011

    Report

    Report Number
    MW5020268
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ARGON
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INTRODUCER NEEDLE IN PLACE IN THE RIGHT INTERNAL JUGULAR, DOCTOR WAS UNABLE TO ADVANCE WIRE FURTHER FOR SHEATH GUIDANCE, NOTED TO BE COILED. UPON REMOVAL OF WIRE, NOTICED THAT IT WAS FRAYED AND SLIGHTLY UNRAVELED. PROCEDURE STOPPED IMMEDIATELY. ADMITTED FOR CAT SCAN WHICH REVEALED WIRE FRAGMENT IN STERNOCLEIDOMASTOID MUSCLE TISSUE. LEFT IN PLACE WITH NO APPARENT HARM TO PT. DIAGNOSIS OR REASON FOR USE: VESSEL DILATOR AND GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGON PERCUTANEOUS INTRODUCER, 7FR DYB ARGON 95-2100-01/1007 99768414

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization