BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL CATHETER

    MDR report key: 7101132 · Received December 8, 2017

    Report

    Report Number
    1226348-2017-10969
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    July 12, 2017
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE. 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. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. IF THE PRODUCT IS RETURNED IN THE FUTUTRE, THIS COMPLAINT WILL BE RE-OPENED AND A FOLLOWUP REPORT WILL BE FILED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿CONVERSION OF EXTERNAL VENTRICULAR DRAINAGE TO VENTRICULO-PERITONEAL SHUNT: TO CHANGE OR NOT TO CHANGE THE PROXIMAL CATHETER?¿ CHILDS NERV SYST, DOI 10.1007/S00381-017-3544-5, IT WAS REPORTED THAT PATIENT # 10, FEMALE (B)(6), PRESENTED WITH CROUZON, ENCEPHALOCELE AND CONGENTITAL HCP, A BACTISEAL EVD WAS PLACED AND THEN LATER CONVERTED TO AN INTERNAL SHUNT SYSTEM WITH AND UNKNOWN VALVE. APPROXIMATELY 9 MONTHS POST CONVERSION PROCEDURE, THE PATIENT DEVELOPED AN INFECTION AND CSF LEAK. THE LEAK WAS TREATED SURGICALLY, WHILE THE VP SHUNT WAS EXTERNALIZED AND THE PATIENT TREATED WITH ANTIBIOTICS. PER THE ARTICLE: ¿IN THIS STUDY, WE INVESTIGATE THE OCCURRENCE RATE OF EARLY SHUNT INFECTION AND MALFUNCTION IN PEDIATRIC PATIENTS AFTER CONVERTING AN EXTERNAL VENTRICULAR DRAINAGE (EVD) TO A VENTRICULO-PERITONEAL SHUNT (VPS) WITHOUT REPLACING THE VENTRICULAR CATHETER¿ IN THE PEDIATRIC POPULATION, THE CONVERSION OF A TUNNELED EVD TO A VPS WITHOUT REPLACING THE VENTRICULAR CATHETER CAN BE SAFELY DONE. CRANIAL ENTRY IS SPARED, WHILE THE RATES OF SHUNT INFECTION AND MALFUNCTION DO NOT INCREASE SIGNIFICANTLY.¿ 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
    879882 UNK BACTISEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention