BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAMIC/VA

    MDR report key: 1021989 · Received March 31, 2008

    Report

    Report Number
    1317056-2008-00022
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 3, 2008
    Manufacturer
    NAMIC/VA
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED GUIDEWIRE HAS BEEN RETURNED AND HAS BEEN FORWARDED TO OUR SUPPLIER FOR THEIR DEVICE ANALYSIS. UPON OBTAINING THE RESULTS OF THEIR INVESTIGATION, A F/U MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED ON END USER MEDWATCH, "ACCESS TO FEMORAL ARTERY WAS GAINED AFTER SEVERAL PASSES, BUT GOOD RETURN OF BLOOD FLOW WAS OBTAINED. THE WIRE WAS ADVANCED THROUGH THE CATHETER. VERY MINIMAL RESISTANCE WAS FELT..TO WIRE ADVANCEMENT AND FLUOROSCOPE REVEALED THE WIRE TO BE CLEARLY ENDOLUMINAL WITHIN THE ILIAC ARTERY. IT COULD BE NOTED, HOWEVER, THAT THERE WAS A DISTINCT BEND IN THE WIRE ABOUT 10-20CM FROM ITS TIP. IT WAS NOTED THAT IN CANNULATING THE SUBCLAVIAN ARTERY THAT THE WIRE PROLAPSED BACK UPON ITSELF. THE APPEARANCE WAS NOT OF A DISTINCT BREAK." THE USED DEVICE IS BEING RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAMIC/VA ANGIOGRAPHIC GUIDEWIRE DQX NAMIC/VA NA 1241041

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other