BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALT GUIDEWIRE 0.018" X 60 CM

    MDR report key: 4824996 · Received May 29, 2015

    Report

    Report Number
    MW5042953
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 29, 2015
    Manufacturer
    GALT
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PICC PLACED TO LEFT LOWER EXTREMITY, PLACEMENT WAS EASY. UPON ATTEMPT TO PULL THE WIRE IT WAS DIFFICULT TO PULL, SO PICC LINE WAS ADJUSTED. SECOND ATTEMPT TO PULL WIRE, MORE BRISKLY THE WIRE PULLED OUT. UPON INSPECTION OF THE WIRE, IT WAS FRAYED AND WAS NOT 60CM IN LENGTH. DR( B)(6) WAS MADE AWARE. XRAYS ORDERED. WIRE ON CHEST XRAY APPEARS TO BE IN-SITU IN HEART. INTERVENTIONAL RADIOLOGY AND CARDIOLOGY CONSULTED BY PICU. WIRE UTILIZED WAS A GALT GUIDEWIRE. CARDIAC CATH LAB UTILIZATION TO RETRIEVE BROKEN WIRE (B)(6) 2015 22:50 TO (B)(6) 2015 AT 01:08. GUIDEWIRE STILL BEING UTILIZED FOR INSERTION OF PICC LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351016 GALT GUIDEWIRE 0.018" X 60 CM GALT GUIDEWIRE 0.018" X 60 CM DQX GALT SGW-019-32

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention