BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL EVD CATHETER

    MDR report key: 7049036 · Received November 21, 2017

    Report

    Report Number
    1226348-2017-10868
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    November 14, 2012
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE. 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 ¿INFECTIONS OF EXTERNAL VENTRICULAR DRAINAGES¿ PUBLISHED EUR. J. MED. ¿ 8(2) ¿ 2013 ¿ 250-256, DOI: 10.2478/S11536-012-0115-8, IT WAS REPORTED THAT 16 UNIDENTIFIED PATIENTS DEVELOPED AN INFECTION AFTER IMPLANTATION OF A BACTISEAL EVD CATHETER. PER THE ARTICLE: ¿THE MOST COMMON COMPLICATION OF THE EXTERNAL VENTRICULAR DRAINAGE (EVD) IS AN INFECTION, WHICH IS LINKED TO DIFFERENT RISK FACTORS. WE TRIED TO INVESTIGATE POSSIBLE LINKS BETWEEN DIFFERENT RISK FACTORS AND INCIDENCES OF AN INFECTION OF THE EVD. MATERIALS AND METHODS. WE USED A RETROSPECTIVE METHOD AND EXAMINED RECORDS OF 176 PATIENTS. THESE PATIENTS WERE ADMITTED TO THE UNIVERSITY(B)(6) BETWEEN JANUARY 2004¿DECEMBER 2005 AND JANUARY 2009¿DECEMBER 2010 AND HAD AN EVD INSERTED. RESULTS. OUR RESEARCH HAD SHOWN A HIGH OVERALL OCCURRENCE OF INFECTION, NAMELY 23.3 %. WE FOUND A SIGNIFICANTLY HIGHER INCIDENCE OF INFECTION IN PATIENTS WITH A SUBARACHNOID HAEMORRHAGE AS AN ETIOLOGY. THE LIKELIHOOD OF AN INFECTION INCREASED WITH EACH CATHETER REPLACEMENT AND WITH EVDS INSERTED FOR MORE THAN 7 DAYS. THE INCIDENCE OF INFECTION IN THE GROUP OF PATIENTS WITH AN IMPREGNATED CATHETER WAS SIGNIFICANTLY LOWER. THE PROTECTIVE ROLE OF IMPREGNATED CATHETERS IS LARGER IN TERMS OF LOCAL EFFECT AND SMALLER IN BROADER EFFECT IN CSF SPACE. CONCLUSIONS. AN EASY RETROGRADE ROUTE FOR MICROORGANISMS TO ENTER VENTRICULAR SPACE SHOULD BE PREVENTED WITH APPROPRIATE CARE AND BY REPLACING EVDS ONLY IN CASES OF MECHANICAL DYSFUNCTION OR EXTRACTION.¿ THERE WAS REPORT OF ANTIBIOTIC TREATMENT FOR THE INFECTIONS, BUT NO DRUG SPECIFIC INFORMATION WAS INCLUDED. THERE WAS REPORT OF DEVICE REVISIONS; HOWEVER, THERE WAS NO DIRECT RELATIONSHIP BETWEEN THE INFECTIONS AND THE DEVICE REVISIONS. 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
    830830 UNK BACTISEAL EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention