BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAMILTON VENTRICULAR DRAINAGE ANTIMICROBIAL CATHETER

    MDR report key: 516438 · Received March 18, 2004

    Report

    Report Number
    1820334-2004-00163
    Event Type
    Other
    Date Received
    March 18, 2004
    Date of Event
    September 26, 2003
    Report Date
    February 20, 2004
    Manufacturer
    COOK, INC.
    Product Code
    NHC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED WITH ANEURYSMAL SAH IN 2003 (CT-1) AND UNDERWENT COILING OF A LEFT PCOMM ANEUYRYSM. A CATHETER WAS PLACED ON FOR EVIDENCE OF HYDROCEPHALUS. A SCAN IN 10/2003 DEMONSTRATES THE CATHETER IN GOOD POSITION(CT-2). THE CATHETER WAS REMOVED THE NEXT DAY. A FOLLOW-UP CT SCAN PERFORMED THE FOLLOWING DAY REVEALS A FOCAL AREA OF HIGH DENSITY ADJACENT TO THE RIGHT FRONTAL HORN THAT APPEARS TO BE THE DISTAL TIP OF THE CATHETER OR A RADIO-OPAQUE MARKER (CT-3). A REPEAT CT SCAN PERFORMED TWO DAYS LATER DEMONSTRATES PERSISTENCE OF THIS AREA OF HIGH-SIGNAL INTENSITY (CT-4). THIS WAS THE FIRST CATHETER PLACED IN THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON VENTRICULAR DRAINAGE ANTIMICROBIAL CATHETER VENTRICULAR CATHETER NHC COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other