BEUDAMED
    FDA Adverse Event Summary report: N

    MICROPUNCTURE KIT 4 FR

    MDR report key: 1970628 · Received January 14, 2011

    Report

    Report Number
    1970628
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 5, 2011
    Manufacturer
    COOK MEDICAL, INC.
    Product Code
    DYB
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEEDLE AND WIRE WERE WITHDRAWN TOGETHER, WIRE BROKE OFF IN PATIENT'S SUBCUTANEOUS TISSUE.====================== HEALTH PROFESSIONAL'S IMPRESSION:ACCORDING TO THE VASCULAR SURGEON, FELT THAT THE WIRE SHOULD NOT HAVE PULLED AWAY WITH THE NEEDLE AND ALSO CONTRIBUTED TO OUTCOME WAS THE PATIENT'S ANATOMY, SCAR TISSUE WITHIN THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE KIT 4 FR INTRODUCER, CATHETER DYB COOK MEDICAL, INC. RCFN-4.0 18 MPIS 2576429

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR