BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOFOCUS GLIDEWIRE

    MDR report key: 1845017 · Received September 22, 2010

    Report

    Report Number
    MW5017576
    Event Type
    Injury
    Date Received
    September 22, 2010
    Manufacturer
    TERUMO CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED ON (B)(6)2010, FOR LEFT HEART CATHETERIZATION. WHILE ATTEMPTING DIFFICULT ACCESS TO RFA IT WAS NOTED THAT WIRE TIP SHEARED OFF. SURGEON DOCUMENTED, DURING THE CARDIAC CATHETERIZATION, ATTEMPTED TO GAIN ACCESS FROM THE RFA APPROACH. GUIDE WIRE EXCHANGES WERE MADE INCLUDING A GUIDEWIRE EXCHANGE WITH A GLIDE WIRE..ATTEMPT WAS MADE TO WITHDRAW GLIDE WIRE THROUGH NEEDLE AND THE DISTAL TIP WAS DISLODGED AND SEPARATED..." UNABLE TO RETRIEVE BY NORMAL METHODS RESULTING IN SURGICAL INTERVENTION (ARTERIAL CATHETERIZATION) PER VASCULAR SURGEON AND ADMISSION TO HOSPITAL FOR CLOSE OBSERVATION. DATES OF USE: (B)(6)2010. DIAGNOSIS OR REASON FOR USE: LEFT CARDIAC CATHETERIZATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOFOCUS GLIDEWIRE GUIDE WIRE DQX TERUMO CORPORATION GR3510 0.035', 150CM 090803

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R