BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL VENTRICULAR CATHETER

    MDR report key: 7112009 · Received December 13, 2017

    Report

    Report Number
    1226348-2017-10980
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    January 11, 2010
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT AVAILABLE

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿IMPACT OF A STANDARDIZED PROTOCOL AND ANTIBIOTIC-IMPREGNATED CATHETERS ON VENTRICULOSTOMY INFECTION RATES IN CEREBROVASCULAR PATIENTS¿ PUBLISHED NEUROSURGERY 67:187-191, 2010 DOI: 10.1227/01.NEU.0000370247.11479.B6, IT WAS REPORTED THAT 2 UNIDENTIFIED PATIENTS DEVELOPED INFECTION AFTER IMPLANTATION OF UNKNOWN BACTISEAL CATHETERS AND THE AN UNKNOWN NUMBER OF BACTISEAL CATHETERS BECAME BLOCKED POST IMPLANTATION. PER THE ARTICLE: ¿DURING PERIOD 3, BEGINNING IN THE FOURTH QUARTER OF 2004, THIS STANDARDIZED PROTOCOL WAS SUPPLEMENTED SYSTEMATICALLY WITH AN ANTIBIOTIC-IMPREGNATED VENTRICULOSTOMY CATHETER (CATHETER A¿CODMAN BACTISEAL VENTRICULAR CATHETER [CODMAN, A JOHNSON AND JOHNSON COMPANY, (B)(4)], IMPREGNATED WITH 0.15% CLINDAMYCIN AND 0.54% RIFAMPIN). THIS CATHETER HAD AN UNACCEPTABLY HIGH RATE OF OCCLUSION, PROMPTING TERMINATION OF ITS USE IN THE FIRST QUARTER OF 2005¿. ADDITION OF ANTIBIOTIC-IMPREGNATED VENTRICULOSTOMY CATHETER A TO THE PREVIOUS STANDARDIZED PROTOCOL MARKED THE THIRD OBSERVATIONAL PERIOD (PERIOD 3). DURING THIS INTERVAL, IN WHICH THE ANTIBIOTIC-IMPREGNATED VENTRICULAR CATHETER WAS USED EXCLUSIVELY, THE INFECTION RATE WAS LOWERED TO 1.0% (2/195 INFECTIONS). THIS WAS A SIGNIFICANT REDUCTION FROM THE BASELINE OBSERVATIONAL PERIOD (PERIOD 1) ¿. UNFORTUNATELY, THE RIFAMPICIN/CLINDAMYCIN-IMPREGNATED VENTRICULOSTOMY CATHETER (CATHETER A) HAD A SIGNIFICANT OCCLUSION RATE IN OUR EXPERIENCE. THIS OCCLUSION RATE WAS BELIEVED TO BE CAUSED BY CLOGGING OF THE DISTAL CATHETER HOLES (SMALLER THAN STANDARD VENTRICULOSTOMY HOLES) FROM SUBARACHNOID AND INTRAVENTRICULAR HEMORRHAGE. THIS UNACCEPTABLY HIGH OCCLUSION RATE PROMPTED DISCONTINUATION OF THIS CATHETER AT OUR INSTITUTION DURING THE END OF THE FIRST QUARTER OF 2005.¿ NO SPECIFIC TREATMENT REGIMEN WAS REPORTED FOR THE INFECTIONS; HOWEVER, THE BLOCKED CATHETERS WERE REVISED. 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
    892893 UNK BACTISEAL VENTRICULAR CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention