BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL EVD CATHETER

    MDR report key: 7049512 · Received November 21, 2017

    Report

    Report Number
    1226348-2017-10870
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    June 24, 2003
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE. IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT, THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿EVALUATION OF AN ANTIBIOTIC-IMPREGNATED SHUNT SYSTEM FOR THE TREATMENT OF HYDROCEPHALUS¿ PUBLISHED J NEUROSURG 99:831¿839, 2003, IT WAS REPORTED THAT 3 UNIDENTIFIED PATIENTS HAD INFECTION DEVELOP AFTER INSERTION OF BACTISEAL CATHETERS. PER THE ARTICLE: ¿STAPHYLOCOCCUS SPECIES ARE THE MOST COMMON ORGANISMS RESPONSIBLE FOR INFECTION FOLLOWING IMPLANTABLE CEREBROSPINAL FLUID (CSF) DIVERSIONARY PROCEDURES. THE ROLE OF AN ANTIBIOTIC-IMPREGNATED SHUNT (AIS) SYSTEM IN THE PREVENTION OF SHUNT INFECTION HAS REMAINED UNCLEAR BECAUSE NO HUMAN CLINICAL TRIAL HAS BEEN REPORTED ON THUS FAR. IN THIS STUDY, THE AUTHORS ASSESS AN AIS SYSTEM WITH RESPECT TO ITS PREVENTION OF SHUNT INFECTION. ONE HUNDRED TEN PATIENTS WERE RECRUITED; 60 RECEIVED CONTROL SHUNT SYSTEMS AND 50 RECEIVED AIS SYSTEMS. THIRTEEN SHUNT INFECTIONS WERE RECORDED (10 IN THE CONTROL GROUP AND THREE IN THE AIS GROUP). NINE OF 13 INFECTIONS OCCURRED WITHIN 2 MONTHS AFTER SHUNT IMPLANTATION (EIGHT OF 10 IN THE CONTROL GROUP AND ONE OF THREE IN THE AIS GROUP). APART FROM ONE PATIENT IN WHOM NO ORGANISM WAS IDENTIFIED, A TOTAL OF 14 ORGANISMS (12 PATIENTS) WERE CULTURED FROM EITHER THE CSF (NINE) OR THE SHUNT APPARATUS (THREE). STAPHYLOCOCCUS SPECIES ACCOUNTED FOR THE MAJORITY OF SHUNT INFECTIONS: ALL 10 CONTROL SHUNTS WERE FOUND TO HAVE A POSITIVE CULTURE OF STAPHYLOCOCCI, WHEREAS NONE OF THE AISS HAD ANY STAPHYLOCOCCI. THE AIS AFFORDED ANTI-STAPHYLOCOCCAL PROTECTION, ESPECIALLY DURING THE EARLY POSTOPERATIVE PERIOD WHEN MOST SHUNT INFECTIONS ARE KNOWN TO OCCUR AND THROUGHOUT THE FOLLOW-UP PERIOD (MEDIAN 9 MONTHS). THE AIS SYSTEM REPRESENTS ANOTHER IMPORTANT TOOL TO ENABLE THE NEUROSURGEON TO PREVENT SHUNT INFECTIONS.¿ IN ALL BUT ONE PATIENT, THE VP SHUNT WAS REMOVED AT THE TIME OF THE INITIAL DIAGNOSIS OF A SHUNT INFECTION, AND EITHER AN EXTERNAL VENTRICULAR DRAIN WAS INSERTED OR, IN THE PRESENCE OF A PATENT ANTERIOR FONTANELLE, INTERMITTENT VENTRICULAR CSF VENTING WAS PERFORMED TO CONTROL THE HYDROCEPHALUS. AT THE TIME OF COMPLAINT ENTRY THERE IS NO CATALOGUE OR LOT NUMBER INFORMATION AVAILABLE. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827173 UNK BACTISEAL EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention