BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 7938120 · Received October 5, 2018

    Report

    Report Number
    1226348-2018-10693
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    August 20, 2008
    Report Date
    September 11, 2018
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    K021653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROVIDED LOT NUMBER WAS NOT VALID FOR THE PRODUCT CODE PROVIDED. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO VALID 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. LOT NUMBER INFORMATION HAS BEEN PROVIDED. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿EFFICACY OF ANTIBIOTIC-IMPREGNATED EXTERNAL VENTRICULAR DRAIN CATHETERS¿ BY S. MUTTAIYAH, S. RITCHIE, S. JOHN, E. MEE, AND S. ROBERTS., PUBLISHED JOURNAL OF CLINICAL NEUROSCIENCE 17 (2010) 296¿298 IT WAS REPORTED THAT AFTER IMPLANT OF AN UNKNOWN BACTISEAL CATHETER, CASE 2 DEVELOPED A STAPH EPIDERMIS INFECTION WITH DEVICE REVISION. THERE WERE 3 DE NOVO EPISODES OF EVD-ASSOCIATED VENTRICULITIS IN THE AI (ANTIBIOTIC IMPREGNATED) GROUP. PER THE ARTICLE: ¿ WE PROSPECTIVELY COMPARED THE INCIDENCE OF VENTRICULITIS ASSOCIATED WITH EXTERNAL VENTRICULAR DRAINS (EVD) IMPREGNATED WITH CLINDAMYCIN AND RIFAMPICIN WITH HISTORICAL CONTROLS. WE FOUND THE USE OF ANTIBIOTIC IMPREGNATED (AI) EVDS SHOWED A SIGNIFICANT DECREASE IN POSITIVE CEREBROSPINAL FLUID CULTURES AND A SIGNIFICANT DELAY IN TIME TO EVD INFECTION.¿ THERE WAS 1 EVENT OF STAPHYLOCOCCUS EPIDERMIS INFECTION, 1 EVENT OF ENTEROCOCCUS SP. INFECTION AND 1EVENT OF CORYNEBACTERIUM SP. INFECTION. THE THREE EPISODES OF EVD-RELATED VENTRICULITIS IN THE AI-GROUP OCCURRED 11 DAYS AFTER INSERTION OF THE THIRD EVD CATHETER, 18 DAYS AFTER INSERTION OF THE SECOND EVD CATHETER AND 16 DAYS AFTER INSERTION OF THE FIFTH EVD CATHETER. THERE IS NO REPORT OF THE TREATMENT GIVEN FOR THE INFECTIONS OR REPORT OF PRODUCT REPLACEMENT. AT THE TIME OF COMPLAINT ENTRY, NO PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778642 CODMAN BACTISEAL EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CGNZ1T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other