BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK, INC-INTRODUCER

    MDR report key: 343404 · Received July 25, 2001

    Report

    Report Number
    343404
    Event Type
    Malfunction
    Date Received
    July 25, 2001
    Date of Event
    June 27, 2001
    Report Date
    July 2, 2001
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CARDIAC CATHETERIZATION PROCEDURE. AT END OF PROCEDURE, ATTEMPTS WERE MADE TO REMOVE SHEATH. TIP OF SHEATH (WITH ONE-WAY VALVE AND SIDE PART) SEPARATED FROM SHEATH CATHETER. PHYSICIAN GRIPPED REMAINING PORTION OF SHEATH AND PULLED IT FROM THE PT'S RIGHT RADIAL ARTERY. NO PT COMPLICATIONS RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33422 COOK, INC-INTRODUCER PLO PERFORMER INTRODUCER SET 6.0FR DYB COOK, INC. RCFN 6.0-18-23-RA2.5 105 2639

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other