BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL CATHETER

    MDR report key: 7047285 · Received November 20, 2017

    Report

    Report Number
    1226348-2017-10861
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    May 8, 2017
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ABSTRACTS FROM 25TH CONGRESS OF THE EUROPEAN SOCIETY FOR PEDIATRIC NEUROSURGERY ¿VENTRICULO -SUBGALEAL SHUNT USING AN ANTIBIOTIC - IMPREGNATED CATHETER: A RETROSPECTIVE ANALYSIS OF OUR INSTITUTIONAL EXPERIENCE¿ PUBLISHED NERV SYST (2016) 32:905¿1012 971, IT WAS REPORTED THAT 3 UNIDENTIFIED CHILDREN HAD COMPLICATIONS AFTER USE OF BACTISEAL CATHETERS; 1 HEMORRHAGE AND 2 INFECTIONS. PER THE ARTICLE: ¿VENTRICULO-SUBGALEAL SHUNT (VSS) IS A TEMPORARY MEASURE TO MANAGE HYDROCEPHALUS, EVENTUALLY OVERCOMING THE RISKS OF EXTERNAL VENTRICULAR DRAINAGE AND SUBCUTANEOUS RESERVOIR¿ WE PERFORMED A RETROSPECTIVE ANALYSIS OF VSS PERFORMED AT OUR INSTITUTION IN THE PERIOD 2013-2015. ANTIBIOTIC IMPREGNATED CATHETER (BACTISEAL® , CODMAN) ALONG WITH A RIGHT ANGLE CONNECTOR WERE USED TO BUILD A PATIENT-TAILORED SHUNT¿ ONE CASE OF HEMORRHAGE SECONDARY TO ABRUPT VENTRICULAR DRAINAGE, THAT DID NOT REQUIRE ADDITIONAL SURGERY, AND TWO CASES OF INFECTION IN PATIENTS WHO UNDERWENT MULTIPLE SURGICAL PROCEDURES (INCLUDING ENDOSCOPY FOR MULTILOCULATED HYDROCEPHALUS). ALL PATIENTS WERE CONVERTED TO A PERMANENT SHUNT EXCEPT FOR 2 PATIENTS WHO DIED BECAUSE OF COMPLICATIONS OF PREMATURITY AND ONE PATIENT WHO WAS MADE SHUNT-FREE WITH ENDOSCOPIC THIRD-VENTRICULOSTOMY.¿ NO FURTHER INFORMATION WAS REPORTED REGARDING THE TREATMENT OR OUTCOME OF THE THREE REPORTED COMPLICATIONS. NO PATIENT SPECIFIC INFORMATION WAS REPORTED. 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
    825265 UNK BACTISEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention