BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL EVD CATHETER

    MDR report key: 7014929 · Received November 9, 2017

    Report

    Report Number
    1226348-2017-10816
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    March 5, 2012
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: DEVICE CODE UNAVAILABLE, UDI UNAVAILABLE. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO 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. COMPLAINT WILL BE CLOSED AS 'NO COMPLAINT SAMPLE RETURNED TO CODMAN FOR EVALUATION'. 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 THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿RISK OF INFECTION AFTER THE PLACEMENT OF AN EXTERNAL VENTRICULAR DRAINAGE CATHETER¿ PUBLISHED SRP ARH CELOK LEK. 2012 MAR-APR;140(3-4):138-141 DOI: 10.2298/SARH1204138N, IT WAS REPORTED THAT 2 UNKNOWN PATIENTS DEVELOPED INFECTION WITH ACINETOBACTER AFTER INSERTION OF UNKNOWN BACTISEAL EVD CATHETERS. PER THE ARTICLE: ¿INTRODUCTION: INFECTION AFTER THE PLACEMENT OF AN EXTERNAL VENTRICULAR DRAINAGE (EVD) CATHETER CAN BE A VERY SERIOUS PROBLEM IN NEUROSURGERY. GOAL OF THE STUDY: THE AIM OF THE STUDY WAS TO EXAMINE WHETHER THE USE OF A SPECIFIC TYPE OF EVD CATHETER REDUCES THE INCIDENCE OF INFECTION. STUDY METHODS: A PROSPECTIVE STUDY WAS CONDUCTED AT THE NI¿ CLINICAL CENTER DEPARTMENT OF NEUROSURGERY BETWEEN 2006 AND 2009. A TOTAL OF 82 PATIENTS, DIVIDED INTO TWO GROUPS, WERE STUDIED. GROUP 1 CONSISTED OF 43 PATIENTS WHO HAD A STANDARD EVD SYSTEM PLACED, WHILE GROUP 2 INCLUDED 39 PATIENTS IN WHOM EVD CATHETERS IMPREGNATED WITH ANTIBIOTICS (RIFAMPICIN AND CLINDAMYCIN ¿ BACTISEAL CATHETERS) WERE USED. RESULTS: IN GROUP 1, NINE PATIENTS DEVELOPED INFECTION, WHICH WAS MOST OFTEN CAUSED BY BACTERIA OF THE GENUS STAPHYLOCOCCUS. IN GROUP 2, ONLY TWO PATIENTS DEVELOPED INFECTION, CAUSED BY THE BACTERIUM ACINETOBACTER. CONCLUSION: THE USE OF A BACTISEAL CATHETER FOR EVD SIGNIFICANTLY REDUCED THE INCIDENCE OF INFECTION AND INCREASED THE NUMBER OF DAYS OF EVD PLACEMENT.¿ THE TWO PATIENTS WERE TREATED WITH ANTIBIOTIC THERAPY AND DEVICE REMOVAL. AFTER DEVICE REMOVAL, THE CATHETER TIPS WERE CULTURED. NEITHER CATHETER TIP HAD ANY BACTERIAL GROWTH AT 48 HOURS. 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
    794068 UNK BACTISEAL EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention