BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL EVD CATHETER

    MDR report key: 7028189 · Received November 14, 2017

    Report

    Report Number
    1226348-2017-10832
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    December 19, 2010
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. HOWEVER, MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE WERE UNSUCCESSFUL. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO PRODUCT OR 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.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿REDUCTION IN EXTERNAL VENTRICULAR DRAIN INFECTION RATE. IMPACT OF A MINIMAL HANDLING PROTOCOL AND ANTIBIOTIC-IMPREGNATED CATHETERS¿ PUBLISHED ACTA NEUROCHIR (2011) 153:647¿651, DOI 10.1007/S00701-010-0905-1, IT WAS REPORTED THAT THREE UNKNOWN PATIENTS DEVELOPED INFECTION AFTER IMPLANTATION OF UNKNOWN BACTISEAL CATHETERS. PER THE ARTICLE: ¿MANY STRATEGIES HAVE BEEN DEVELOPED WITH THE AIM OF REDUCING EXTERNAL VENTRICULAR DRAIN-RELATED INFECTIONS. ANTIBIOTIC-IMPREGNATED CATHETERS ARE ONE OF THEM¿WE REPORT 648 CASES OF EXTERNAL VENTRICULAR DRAIN FROM A TOTAL OF 534 PATIENTS TREATED AT THE VIRGEN DEL ROCÍO HOSPITAL BETWEEN 1995 AND 2006¿ THREE SUBGROUPS WERE CONSIDERED: GROUP 1 INCLUDED PATIENTS TREATED BETWEEN 1995 AND 2000, AS WELL AS A TOTAL OF 190 EXTERNAL VENTRICULAR DRAINS AND 59 CASES OF INFECTION (31.05%); GROUP 2, WITH PATIENTS TREATED BETWEEN 2000 AND 2004 AND MANAGED WITH A MINIMAL HANDLING PROTOCOL, INCLUDED 210 EXTERNAL VENTRICULAR DRAINS AND NINE CASES OF INFECTION (4.29%); AND GROUP 3, TREATED BETWEEN 2004 AND 2006, WITH 248 EXTERNAL VENTRICULAR DRAINS AND SIX CASES OF INFECTION (2.41%). THIS LATTER SUBGROUP INCLUDED PATIENTS MANAGED WITH A MINIMAL HANDLING PROTOCOL AND ANTI-BIOTIC-IMPREGNATED CATHETERS¿MINIMAL HANDLING PROTOCOLS CONSTITUTE AN ESSENTIAL STRATEGY IN THE REDUCTION OF EXTERNAL VENTRICULAR DRAIN-RELATED INFECTIONS. BESIDES THAT, THE USE OF ANTIBIOTIC-IMPREGNATED CATHETERS MAY REDUCE INFECTION-RELATED HOSPITAL COSTS.¿ THERE IS NO SPECIFIC TREATMENT INFORMATION REPORTED IN THE ARTICLE. 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
    809904 UNK BACTISEAL EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NNI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention