BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE

    MDR report key: 26314 · Received August 31, 1995

    Report

    Report Number
    2126666-1995-00001
    Event Type
    Injury
    Date Received
    August 31, 1995
    Date of Event
    August 9, 1995
    Report Date
    August 25, 1995
    Manufacturer
    LAKE REGION MFG. CO., INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ARTERIOGRAM, WHILE ADVANCING THE GUIDE WIRE THROUGH A PIGTAIL CATHETER, THE PHYSICIAN BEGAN NOTICING RESISTANCE. THE VIDEO SCREEN SHOWED THE INNER CORE HAD POPPED OUT OF ONE OF THE SIDE HOLES, & THE EXTERIOR PORTION HAD ADVANCED THROUGH THE NORMAL LUMEN. THE CATHETER WAS REMOVED, NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDEWIRE GUIDEWIRE DQX LAKE REGION MFG. CO., INC. NA 95AM11

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention EKG MONITOR, PULSE OXIMETER| FLOUROSCOPY MACHINE, INTRODUCER SHEATH