BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL EVD CATHETER

    MDR report key: 7111469 · Received December 12, 2017

    Report

    Report Number
    1226348-2017-10978
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    October 26, 2007
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE. IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿THE IMPACT OF ANTIBIOTIC-IMPREGNATED CATHETERS ON SHUNT INFECTION IN CHILDREN AND NEONATES¿ PUBLISHED CHILDS NERV SYST (2008) 24:557¿562, DOI 10.1007/S00381-007-0521-4, IT WAS REPORTED THAT 18 PATIENTS WHO HAD RECEIVED BACTISEAL CATHETERS DEVELOPED INFECTION POST IMPLANTATION. PER THE ARTICLE: ¿INTRODUCTION INFECTION REMAINS A SIGNIFICANT PROBLEM WITH CEREBROSPINAL FLUID (CSF) DIVERSION PROCEDURES. ANTIBIOTIC-IMPREGNATED SHUNT CATHETERS (AIS) HAVE BEEN INTRODUCED TO PREVENT INFECTION, MAINLY IN THE EARLY POST-OPERATIVE PERIOD WHEN MOST INFECTIONS OCCUR. WE EVALUATE THE IMPACT ON INFECTION RATES IN CHILDREN FOLLOWING THE INTRODUCTION OF CATHETERS IMPREGNATED WITH RIFAMPICIN AND CLINDAMYCIN. MATERIALS AND METHODS: THE STUDY WAS A RETROSPECTIVE ANALYSIS OF ALL PAEDIATRIC SHUNT PROCEDURES UNDERTAKEN AFTER THE INTRODUCTION OF AIS SYSTEMS IN 2003. ALL PROCEDURES WHERE A COMPLETE AIS SYSTEM WAS IMPLANTED WERE INCLUDED. FOR THE PURPOSE OF ANALYSIS, SHUNT PROCEDURES WERE CLASSIFIED AS DE NOVO (GROUP 1), CLEAN REVISION (GROUP 2) AND FOLLOWING EXTERNAL VENTRICULAR DRAINAGE WITH EITHER STERILE CSF (GROUP 3) OR INFECTED CSF (GROUP 4). RESULTS WERE COMPARED TO A HISTORICAL COHORT OF SHUNT PROCEDURES UNDERTAKEN BEFORE THE INTRODUCTION OF AIS CATHETERS. RESULTS A TOTAL OF 214 AIS WERE IMPLANTED IN 150 CHILDREN BETWEEN OCTOBER 2003 AND DECEMBER 2006. THERE WERE 4 INFECTIONS IN GROUP 1 (8.5%), 6 INFECTIONS IN GROUP 2 (5.3%) AND 11 INFECTIONS IN GROUPS 3 AND 4 (20%). THE HISTORICAL CONTROL GROUP COMPRISED 77 SHUNTS IN 65 CHILDREN. THE INFECTION RATE IN NEONATAL DE NOVO SHUNTS REDUCED FROM 27 TO 10.4% FOLLOWING THE INTRODUCTION OF AIS CATHETERS. CONCLUSIONS AIS CATHETERS CAN REDUCE THE NUMBER OF SHUNT INFECTIONS SEEN IN CLINICAL PRACTICE IN CERTAIN SUBGROUPS. THIS HAS HAD A SIGNIFICANT IMPACT ON THE NEONATAL HYDROCEPHALIC POPULATION. THE HIGH RISK OF SHUNT INFECTION AFTER A PERIOD OF EXTERNAL VENTRICULAR DRAINAGE RAISES THE ISSUE OF EMERGENCE OF BACTERIAL RESISTANCE¿. OUT OF 214 ANTIBIOTIC-IMPREGNATED SHUNTS IMPLANTED IN 150 PATIENTS, THERE WERE 21 INFECTED SHUNTS OCCURRING IN 18 PATIENTS (3 PATIENTS HAD TWO EPISODES OF SHUNT INFECTION). THEREFORE, OVERALL, THERE WAS A SHUNT INFECTION RATE OF 9.8% PER PROCEDURE. THE MEAN TIME TO SHUNT INFECTION (DEFINED AS DAYS TO SHUNT REMOVAL) WAS 23 DAYS, WITH A RANGE OF 1 TO 73 DAYS.¿ THERE WAS NO PATIENT SPECIFIC INFORMATION REPORTED TO INDIVIDUALLY IDENTIFY THESE PATIENTS. THE INFECTIONS WERE TREATED WITH IV ANTIBIOTICS AND DEVICE REVISIONS. 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
    886945 UNK BACTISEAL EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention