BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQWIRE DIAGNOSTIC GUIDE WIRE

    MDR report key: 3601811 · Received January 17, 2014

    Report

    Report Number
    9616662-2014-00001
    Event Type
    Injury
    Date Received
    January 17, 2014
    Date of Event
    December 24, 2013
    Report Date
    December 24, 2013
    Manufacturer
    MERIT MEDICAL SYSTEM, INC.
    Product Code
    DQX
    PMA / PMN Number
    K002289
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE USER REPORTED AN ADDITIONAL SUSPECT LOT NUMBER FOR THE DEVICE. LOT NUMBER K451597, MANUFACTURE DATE: 02/2013, EXPIRATION DATE: 01/31/2016. A COPY OF THE USER FACILITY MEDWATCH REPORT IS ATTACHED FOR REFERENCE. THE USER FACILITY REPORT DOES NOT CONTAIN A REPORT NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A RADIAL APPROACH CARDIAC CATHETERIZATION PROCEDURE, THE GUIDE WIRE BROKE WHILE IN THE PT'S LEFT MAIN ARTERY AND THE BROKEN FRAGMENT MIGRATED TO THE AORTA. THE PHYSICIAN REPORTED THAT THE GUIDE WIRE GOT CAUGHT INSIDE THE CATHETER AND WHEN HE PULLED ON THE WIRE TO REMOVE IT WHILE KEEPING THE GUIDE CATHETER IN PLACE, THE OUTER COIL MAY HAVE COME OFF. THE WIRE FRAGMENT WAS VISUALIZED UNDER FLUOROSCOPY ENTERING THE LEFT MAIN CORONARY ARTERY AND THEN IT ENTERED THE AORTA AND REMAINED ON TOP OF THE AORTIC VALVE ABOVE THE HEART. THE WIRE FRAGMENT WAS REMOVED USING A SNARE ONCE THE LESION WAS OPENED AND A STENT HAD BEEN PLACED TO SUCCESSFULLY RESTORE FLOW IN THE LEFT MAIN ARTERY. THE INCIDENT DELAYED THE PROCEDURE BY THREE MINUTES. NO ADDITIONAL HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45578 INQWIRE DIAGNOSTIC GUIDE WIRE WIRE, GUIDE, CATHETER DQX MERIT MEDICAL SYSTEM, INC. K365410

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R TERUMO L4 GUIDE CATHETER