BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMACATH, EXTERNAL VENTRICULAR DRAINAGE CATHETER

    MDR report key: 375780 · Received February 6, 2002

    Report

    Report Number
    2648988-2002-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2002
    Report Date
    February 6, 2002
    Manufacturer
    HEYER SCHULTE NEUROCARE INC
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS WHEN INSERTING THE CATHETER INTO THE HOLE, THE LARGER HOLE IS TRAPPING BRAIN TISSUE. CSF CAN NOT DRAIN INTO THE CATHETER HOLES. THE SURGEON HAS DISCARDED THE PRODUCT. SURGEON'S COMMENT/SUGGESTION: IF THE TROCAR WAS LARGER THAN IT WOULD NOT BLOCK THE HOLES. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAUMACATH, EXTERNAL VENTRICULAR DRAINAGE CATHETER EXTERNAL CSF DRAINAGE CATHETERS JXG HEYER SCHULTE NEUROCARE INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention