BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACTISEAL CATHETER

    MDR report key: 6959663 · Received October 18, 2017

    Report

    Report Number
    1226348-2017-10770
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    October 12, 2004
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. ATTEMPTS TO HAVE THE SAMPLE RETURNED WERE NOT SUCCESSFUL. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. 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 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 ¿INITIAL EXPERIENCE WITH ANTIBIOTIC-IMPREGNATED SILICONE CATHETERS FOR SHUNTING OF CEREBROSPINAL FLUID IN CHILDREN¿ PUBLISHED CHILDS NERV SYST (2005) 21:56¿61 DOI 10.1007/S00381-004-1052-X, IT WAS REPORTED THAT PATIENT # 13 HAD CATHETER DISCONNECTION / MIGRATION AFTER IMPLANTATION IF A VENTRICULOPERITONEAL SHUNT USING THE CODMAN BACTISEAL CATHETER SYSTEM. PER THE ARTICLE: ¿INFECTION IS A MAJOR COMPLICATION OF CEREBROSPINAL FLUID (CSF) SHUNTING PROCEDURES. RECENTLY, RIFAMPIN-IMPREGNATED AND CLINDAMYCIN-IMPREGNATED SILICONE CATHETERS HAVE BEEN DEVELOPED IN AN ATTEMPT TO PREVENT AND/OR REDUCE THE INCIDENCE OF SHUNT INFECTIONS. IN VITRO AND IN VIVO ANIMAL STUDIES HAVE SHOWN THEIR EFFICACY IN REDUCING BACTERIAL COLONIZATION OF CATHETERS. HOWEVER, THESE SHUNTS ARE YET TO BE EVALUATED IN CLINICAL TRIALS AND THEIR SAFETY AND EFFICACY IN PREVENTING SHUNT INFECTIONS IS UNKNOWN.¿ REVISION OF THE DEVICE WAS PERFORMED AND NO FURTHER EVENTS WERE REPORTED. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738642 BACTISEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention