BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAXIAL MICROPUNCTURE INTRODUCER SET

    MDR report key: 320283 · Received March 12, 2001

    Report

    Report Number
    1820334-2001-00023
    Event Type
    Other
    Date Received
    March 12, 2001
    Date of Event
    February 13, 2001
    Report Date
    February 13, 2001
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS BEING UTILIZED DURING ATTEMPTED PLACEMENT OF A HICKMAN CENTRAL VENOUS CATHETER. DURING ATTEMPTED PLACEMENT OF THE WIRE GUIDE, THE TIP BECAME KINKED. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE WIRE GUIDE BACK THROUGH THE NEEDLE LEVEL. DURING WITHDRAWL, THE TIP OF THE WIRE GUIDE SEPARATED AND WENT INTO A COLLATERAL BLOOD VESSEL. THIS SEPARATED SEGMENT WILL NOT BE REMOVED ACCORDING TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11128 COAXIAL MICROPUNCTURE INTRODUCER SET SPECIAL SET DYB COOK INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other