BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL VENTRICULAR CATHETER

    MDR report key: 3805843 · Received May 12, 2014

    Report

    Report Number
    3805843
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 1, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GYK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, PT WENT TO MD FOR FIVE MONTH FOLLOW-UP. PT HAD MRI THIS DAY. MOM AND GRANDMOTHER VOICED CONCERN OVER BABY HAVING EXTREME IRRITABILITY, NOT SLEEPING, WAKING UP SCREAMING AND HOLDING EARS AND BACK OF HEAD WHEN CRYING. A SHUNT TAP WAS PERFORMED AND THERE WAS NO SPONTANEOUS FLOW. THERE WAS MINIMAL FLOW WITH NEGATIVE SUCTIONING. MOM REPORTS BABY FUSSY AND CRIES AT NIGHTS DURING SLEEP. BABY HAS RECENTLY HAD INCREASE IN FUSSINESS AND IRRITABILITY, SOME SWELLING OVER THE FOREHEAD. RECOMMENDATIONS WERE A PROXIMAL SHUNT REVISION. BABY BROUGHT TO THE HOSPITAL ON (B)(6) 2014 AND SURGERY PERFORMED. OLD PROXIMAL CATHETER WHEN DISCONNECTED FROM THE SHUNT VALVE THERE WAS VERY SLOW CEREBROSPINAL FLUID LEAKING SO THE OLD PROXIMAL CATHETER WAS REMOVED. WHEN THE CATHETER WAS REMOVED THERE WAS SOME INTRAVENTRICULAR BLEED NOTED. THIS AREA ADDRESSED THEN A NEW CATHETER WAS CONNECTED TO THE EXISTING VALVE. VALVE TAPPED AND CSF OBTAINED. ALSO CHECKED THE DISTAL RUN-OFF AND THERE WAS ADEQUATE RUN-OFF. NOT ENOUGH ROOM FOR BRAND NAME. DEVICE USED BACK IN 2012 WAS A CODMAN BACTISEAL VENTRICULAR CATHETER AND DISTAL CATHETER KIT WITH BACTISEAL SHUNT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284060 CODMAN BACTISEAL VENTRICULAR CATHETER VENTRICULAR CATHETER FOR SHUNT GYK CODMAN & SHURTLEFF, INC. CNHBBG

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Hospitalization