BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW SELECT KIT

    MDR report key: 1212303 · Received October 3, 2008

    Report

    Report Number
    1212303
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 27, 2008
    Report Date
    October 3, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    LEFT FEMORAL ARTERIAL LINE PLACEMENT IN ER. AFTER THE CATHETER WAS PLACED OVER GUIDEWIRE, THE GUIDEWIRE SHEARED AND COULD NOT BE REMOVED WITHOUT REMOVAL OF THE CATHETER. THIS WAS ACCOMPLISHED AND THE ENTIRE WIRE WAS RETRIEVED, BUT THERE WAS UNRAVELING OF THE WIRE WITH CONCERN THAT A PIECE OF IT COULD BREAK OFF. THAT DID NOT HAPPEN. THERE WAS ARTERIAL BLEEDING FROM THE SITE THAT REQUIRED FIFTEEN MINUTES OF DIRECT PRESSURE TO CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW SELECT KIT GUIDEWIRE DQO TELEFLEX MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR