BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL CATHETER

    MDR report key: 7061473 · Received November 27, 2017

    Report

    Report Number
    1226348-2017-10890
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    September 29, 2013
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. HOWEVER, MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE WERE UNSUCCESSFUL. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO PRODUCT OR LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE FOR CONFERENCE ABSTRACT ¿41ST ANNUAL MEETING OF THE INTERNATIONAL SOCIETY FOR PEDIATRIC NEUROSURGERY, MAINZ, GERMANY, SEPT 29~OCT 3, 2013: PAEDIATRIC BACTISEAL EXTERNAL VENTRICULAR DRAINS: A REPORT ON CSF SAMPLING AND TIME TO INFECTION¿ PUBLISHED CHILDS NERV SYST (2013) 29:1689¿1784, DOI 10.1007/S00381-013-2261-Y, IT WAS REPORTED THAT 4 UNIDENTIFIED PATIENTS DEVELOPED INFECTIONS POST IMPLANTATION OF BACTISEAL CATHETERS FOR CSF SHUNTING. THERE WAS NO PATIENT SPECIFIC INFORMATION OR TREATMENT REGIMEN DATA REPORTED. PER THE ABSTRACT: ¿OBJECTIVES: EXTERNAL VENTRICULAR DRAINS (EVD) CARRY AN INFECTION RISK, HOWEVER NO CURRENT GUIDELINES REGARDING TIMING AND FREQUENCY OF CSF SAMPLING EXIST. WE AIM TO IDENTIFY THE LENGTH OF TIME THAT EVDS LEFT IN SITU REMAINED INFECTION FREE AND THE TIMING OF CSF SAMPLING. PATIENTS: 70 (M-40, F-30) CHILDREN UNDERWENT BACTISEAL EVD INSERTION AND CSF SAMPLING BETWEEN 2007 AND 2011. MEDIAN AGE 4 (12D¿15) YEARS. POSITIVE CSF CULTURE AT INSERTION AND REPEAT/SECOND EVD INSERTIONS WERE EXCLUDED. PRIMARY OUTCOME MEASURE: POSITIVE CSF CULTURE. SHUNT-RELATED AND NON-SHUNT RELATED EVD WERE COMPARED. RESULTS: 68.6% WERE NON-SHUNT RELATED, INCLUDING 40% EVD INSERTIONS FOR NEOPLASM-RELATED HYDROCEPHALUS. SHUNT RELATED EVD (31.4%) INCLUDED 17% SHUNT INFECTIONS. 6% (4/62) OF CHILDREN BECAME CSF POSITIVE ON DAYS 5, 9, 28, 31. 75% (3/4) GREW STAPHYLOCOCCUS AUREUS. INFECTION IN NON- SHUNT RELATED EVD WAS PRESENT IN 2.2% (1/46) AND IN 19% (3/16) OF SHUNT RELATED EVD (P <0.02). MEDIAN TIME TO INFECTION WAS 9 DAYS IN THE SHUNT RELATED GROUP AND 28 DAYS IN THE NON-SHUNT RELATED CASES. USING THE KAPLAN-MEIER SURVIVAL CURVE, THE DAILY PROBABILITY OF CSF REMAINING CULTURE-NEGATIVE WAS >92% UNTIL THE 9TH DAY POST EVD INSERTION. CONCLUSIONS: LOW INFECTION FREQUENCY IN NON-SHUNT RELATED EVD DOES NOT SUPPORT ROUTINE CSF SAMPLING IN THIS SUBGROUP. TIME-TO-INFECTION IN NON-SHUNT RELATED EVD IS LONGER THAN IN SHUNT-RELATED EVD. OVERALL LOW CSF INFECTION RATE (6.2%) DOES NOT SUPPORT REGULAR SAMPLING OF CSF BEFORE DAY 5. OVER 92% BACTISEAL EVD SURVIVAL TO DAY 9 SUGGESTS DELAYED NEED FOR EVD REPLACEMENT.¿ 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
    838459 UNK BACTISEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention