BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BACTISEAL EVD CATHETER

    MDR report key: 7087619 · Received December 6, 2017

    Report

    Report Number
    1226348-2017-10928
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    June 24, 2012
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE, UDI UNAVAILABLE. 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. COMPLAINT WILL BE CLOSED AS 'NO COMPLAINT SAMPLE RETURNED TO CODMAN FOR EVALUATION'. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿SELECTIVE USE OF INTRA-CATHETER ENDOSCOPIC-ASSISTED VENTRICULAR CATHETER PLACEMENT: INDICATIONS AND OUTCOME¿ PUBLISHED CHILDS NERV SYST (2012) 28:1163¿1169, DOI 10.1007/S00381-012-1838-1, IT WAS REPORTED THAT PATIENT #13, AN (B)(6) AT THE TIME OF SURGERY, STATUS POST IVH (INTRA-VENTRICULAR HEMORRHAGE) AND FAILURE OF AN UNKNOWN PREVIOUS SHUNT, HAD INTRAPARENCHYMAL PLACEMENT OF THE BACTISEAL VENTRICULAR CATHETER THAT NECESSITATED IMMEDIATE REVISION THE FOLLOWING DAY. PER THE ARTICLE: ¿IN A PREVIOUS WELL-CONTROLLED STUDY, ROUTINE ENDOSCOPIC-GUIDED PLACEMENT OF VENTRICULAR CATHETERS DID NOT SEEM TO DECREASE THE RATE OF SHUNT FAILURE OR PROXIMAL SHUNT MALFUNCTION. SINCE THIS STUDY WAS PUBLISHED, THIS TECHNIQUE DOES NOT SEEM TO GAIN MUCH ACCEPTANCE. HOWEVER, IN SELECTED CASES, IT MAY ASSIST IN ACCURACY AND SAFETY. WE THEREFORE HAVE ANALYZED OUR EXPERIENCE WITH SELECTIVE INTRACATHETER ENDOSCOPIC USE FOR VENTRICULAR HARDWARE PLACEMENT¿ DURING 25 MONTHS, FEBRUARY 2010 ¿ MARCH 2012, 16 CHILDREN (AGES 3 MONTHS¿ 18 YEARS) UNDERWENT 18 PROCEDURES USING THE ABOVE TECHNIQUE. INDICATIONS FOR SURGERY WERE: PROXIMAL SHUNT MALFUNCTION WITH RELATIVELY SMALL VENTRICLES (TEN CHILDREN), PROXIMAL SHUNT MALFUNCTION WITH INTRAVENTRICULAR MEMBRANES (ONE CHILD), PROXIMAL SHUNT MALFUNCTION WITH DISTORTED VENTRICLES (ONE CHILD), NEW SHUNT WITH SMALL TO MEDIUM SIZED VENTRICLES (TWO CHILDREN), OR LARGE VENTRICLES AND A LOCULATED FOURTH VENTRICLE SECONDARY TO AN AQUEDUCTAL WEB (TWO CHILDREN). FOURTEEN PROCEDURES WERE TECHNICALLY SUCCESSFUL. THE CATHETER WAS PROPERLY LOCATED ON POSTOPERATIVE IMAGING IN 13 PROCEDURES. FRAMELESS NAVIGATION WAS USED IN THREE CASES¿ SELECTIVE USE OF INTRA-CATHETER ENDOSCOPIC-ASSISTED PROXIMAL SHUNT PLACEMENT IS USEFUL AND MAY BE INDICATED IN SMALL OR DISTORTED VENTRICLES AND IN CASES WHEN FENESTRATION OF AN INTRAVENTRICULAR MEMBRANE OR AQUEDUCTAL WEB IS INDICATED. THE MAIN VALUE OF SUCH A TECHNIQUE IS THE ABILITY TO ACCURATELY PLACE THE CATHETER TIP WITHIN DISTORTED OR SMALL VENTRICLES. LARGER SERIES ARE NEEDED TO REFINE THESE INDICATIONS.¿ THERE WAS NO OTHER PATIENT SPECIFIC INFORMATION AVAILABLE. THERE WAS NO REPORT OF OTHER ADVERSE EVENTS OR PRODUCT MALFUNCTIONS FOR THIS PATIENT.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
    866207 UNK BACTISEAL EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention