BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAXIAL MICRO-PUNCTURE INTRODUCER SET

    MDR report key: 1060388 · Received June 12, 2008

    Report

    Report Number
    1820334-2008-00301
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 15, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING COOK'S COAXIAL MICRO-PUNCTURE INTRODUCER SET TO ACCESS A FEMORAL ARTERY. THE PHYSICIAN ACCESSED WITH THE NEEDLE, AND WHEN HE PUT THE WIREGUIDE INTO THE NEEDLE IT BECAME STUCK AND HE HAD TO PULL THE NEEDLE AND WIRE OUT TOGETHER. WHEN HE DID THAT, THE WIRE UNRAVELLED AND PIECE WAS LEFT IN THE PT. THE PHYSICIAN BELIEVES THE WIRE IS OUTSIDE OF THE ARTERY AND IN THE TISSUE TRACT. AT THIS TIME IT IS UNK IF ADD'L INTERVENTION WAS TAKEN TO REMOVE THE WIRE THAT WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAXIAL MICRO-PUNCTURE INTRODUCER SET DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2060998

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention