BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS MICRO ACCESS GUIDEWIRE

    MDR report key: 5999422 · Received October 3, 2016

    Report

    Report Number
    MW5065175
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 3, 2016
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT WITH A HISTORY OF PERIPHERAL ARTERIAL DISEASE WAS TAKEN TO THE CATH LAB FOR PERIPHERAL ARTERIOGRAM AND POSSIBLE INTERVENTION. THE MICROPUNCTURE NEEDLE WAS INTRODUCED VIA THE RIGHT GROIN INTO THE ARTERIAL BASE VIA MODIFIED SELDINGER APPROACH WITH A SINGLE ANTERIOR WALL STICK. THE MICROPUNCTURE WIRE WAS PACKED INTO THE MICROPUNCTURE NEEDLE WHERE UPON UNDER FLUOROSCOPY, WAS NOTED TO BE COILED. ATTEMPT WAS MADE TO EXTRACT THE WIRE USING GENTLE TRACTION, RESULTING IN UNRAVELING OF THE WIRE TIP WITH RETAINED FOREIGN BODY. THE RETAINED WIRE WAS SUCCESSFULLY EXTRACTED FROM THE RIGHT GROIN VIA INCISION INTO THE SUBCUTANEOUS TISSUE WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644978 ANGIODYNAMICS MICRO ACCESS GUIDEWIRE MICROACCESS GUIDEWIRE DQX ANGIODYNAMICS, INC. 50G8283

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention