BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL EVD CATHETER

    MDR report key: 7122182 · Received December 15, 2017

    Report

    Report Number
    1226348-2017-10983
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    September 8, 2008
    Report Date
    November 15, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI -- UNKNOWN, NO PRODUCT INFORMATION PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION, INCLUDING WHETHER THE DEVICE IS AVAILABLE FOR RETURN. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿ANTIBIOTIC IMPREGNATED EXTERNAL VENTRICULAR DRAINAGE AND THIRD VENTRICULOSTOMY IN THE MANAGEMENT OF HYDROCEPHALUS ASSOCIATED WITH POSTERIOR CRANIAL FOSSA TUMOURS¿ BY GIANPIERO TAMBURRINI & LUCA MASSIMI & MASSIMO CALDARELLI AND CONCEZIO DI ROCCO, PUBLISHED ACTA NEUROCHIR (WIEN) (2008) 150:1049¿1056, DOI 10.1007/S00701-008-0022-6, IT WAS REPORTED THAT ONE UNIDENTIFIED PATIENT DEVELOPED INFECTION AFTER INSERTION OF THE BACTISEAL EVD CATHETER. PER THE ARTICLE: ¿BACKGROUND THE EFFECTIVENESS OF ANTIBIOTIC PRE-TREATED VENTRICULAR CATHETERS IN REDUCING THE RISK OF CSF INFECTIONS (DETERMINED ON CSF CULTURES) RESULTING FROM THE USE OF PER-OPERATIVE EXTERNAL VENTRICULAR DRAINAGES (EVD) AND THE SUCCESS RATE OF POST-OPERATIVE ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) IN THE MANAGEMENT OF PERSISTENT HYDROCEPHALUS AFTER POSTERIOR CRANIAL FOSSA TUMOUR REMOVAL ARE ASSESSED¿. ANTIBIOTIC PRE-TREATED CATHETERS IN OUR EXPERIENCE CONSIDERABLY LIMITED EVD-RELATED BACTERIAL GROWTH IN THE CSF. PREOPERATIVE HYDROCEPHALUS RESOLVED IN 60% OF THE CASES AFTER TUMOUR REMOVAL, THUS CONFIRMING RECENT DATA FROM THE LITERATURE AGAINST THE ROUTINE USE OF PREOPERATIVE ETV. IN OUR EXPERIENCE, POSTOPERATIVE ETV HAD A HIGH SUCCESS RATE; POOR RESULTS WERE OBTAINED IN CHILDREN WITH TUMOUR SEEDING AND/OR THE EVIDENCE OF POSITIVE CSF CULTURES¿. COMPLICATIONS RELATED TO THE PROTOCOL WERE REPRESENTED BY ONE POSITIVE CSF CULTURE (STAPHYLOCOCCUS EPIDERMIDIS), OCCURRED DURING THE POST-OPERATIVE EVD TIME (1/47 PATIENTS: 2.1%), WITHOUT CLINICAL SIGNS OF CSF INFECTION; THIS PATIENT WAS TREATED WITH VENTRICULAR CATHETER SUBSTITUTION AND A 10 DAYS CYCLE OF INTRAVENTRICULAR ANTIBIOTIC THERAPY (VANCOMYCIN: 10 MG/DAY), WHICH ALLOWED THE RESOLUTION OF THE CSF BACTERIAL GROWTH.¿ AT THE TIME OF COMPLAINT ENTRY THERE IS NO CATALOGUE OR LOT NUMBER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899538 UNK BACTISEAL EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention