BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE

    MDR report key: 34051 · Received June 7, 1996

    Report

    Report Number
    1219544-1996-00004
    Event Type
    Injury
    Date Received
    June 7, 1996
    Report Date
    June 7, 1996
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INCIDENT OCCURRED WHILE PERFORMING A LEFT HEART CATHETERIZATION. THE WIRE WAS ADVANCED THROUGH AN ENTRY NEEDLE THROUGH VERY TORTUOUS ANATOMY. THE WIRE WAS PULLED BACK THROUGH AN ENTRY NEEDLE TO REPOSITION IT WHEN THE COATING SHEARED AND PIECES DETACHED IN THE PT. ALL PIECES WERE SUCCESSFULLY RETRIEVED. THE PT EXPERIENCED NO SEQUELAE AS A RESULT OF THIS EVENT. NO PT INFO WAS AVAILABLE DUE TO PT CONFIDENTIALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDEWIRE GLIDEWIRE DQX TERUMO MEDICAL CORP. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention