BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MARKED SPRING-WIRE GUIDE

    MDR report key: 3212772 · Received July 3, 2013

    Report

    Report Number
    MW5030786
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ARROW INTL, INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE TIP (APPROX 16 CM) OF THE ARROW MARKED SPRING-WIRE GUIDE WAS RETAINED IN A PT'S LEFT INTERNAL JUGULAR (IJ) AFTER IT WAS UNABLE TO BE THREADED AT THE TIME OF INSERTION. THE PT'S VASCULATURE WAS NOTED TO BE PREVIOUSLY OCCLUDED PROXIMALLY. THE WIRE IS DESIGNED TO BE LESS RIGID AT THE INSERTION END, HOWEVER, THIS MAY ALLOW BREAKAGE AT THE POINT WHERE THE WIRE BECOMES RIGID IN NATURE FOR INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305966 ARROW MARKED SPRING-WIRE GUIDE NONE DQX ARROW INTL, INC REF AW-04432 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR