BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS

    MDR report key: 540412 · Received May 5, 2004

    Report

    Report Number
    540412
    Event Type
    Injury
    Date Received
    May 5, 2004
    Date of Event
    May 4, 2004
    Report Date
    May 5, 2004
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF ARTERIAL LINE GUIDEWIRE BROKE OFF INTO TWO PIECES DURING REMOVAL. PT TAKEN TO O.R. AND CUTDOWN PERFORMED. DISTAL PORTION OF WIRE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIODYNAMICS BENTSON GUIDEWIRE DQX ANGIODYNAMICS * 07953909

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention