BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARES ANTIBIOTIC-IMPREGNATED CATHETER KIT

    MDR report key: 8378780 · Received February 28, 2019

    Report

    Report Number
    9612164-2019-00731
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    February 15, 2019
    Report Date
    June 26, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169762664
    PMA / PMN Number
    K110560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE INCLUDED PART NUMBER (PN) 17358-1 VENTRICULAR CATHETER AND PN 17359-1 CARDIAC/PERITONEAL CATHETER. 47 INCHES OF THE CARDIAC/PERITONEAL CATHETER WAS RETURNED. THE CARDIAC/PERITONEAL CATHETER MET THE REQUIREMENTS FOR LEAK, PATENCY AND TENSILE TESTING. THE VENTRICULAR CATHETER WAS RETURNED IN TWO SEGMENTS, THE LONGEST BEING 5.4 INCHES AND THE OTHER BEING 2.4 INCHES. DUE TO THE LENGTH OF THE VENTRICULAR CATHETER THAT WAS RETURNED, ONLY ONE TENSILE TEST COULD BE PERFORMED. THE SAMPLE OF THE VENTRICULAR CATHETER THAT WAS TESTED MET THE REQUIREMENTS FOR TENSILE TESTING. THE VENTRICULAR CATHETER COULD NOT BE TESTED FOR LEAK AND PATENCY DUE TO THE DAMAGE. THREE OF THE ENDS OF THE TWO SEGMENTS RETURNED WERE DAMAGED. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE INSTRUCTION FOR USE CAUTIONS, ¿IMPROPER USE OF INSTRUMENTS IN HANDLING OR IMPLANTING SHUNT PRODUCTS MAY RESULT IN THE CUTTING, SLITTING OR CRUSHING OF COMPONENTS. SUCH DAMAGE MAY LEAD TO LOSS OF SHUNT INTEGRITY¿¿ PROTEINACEOUS DEBRIS WAS OBSERVED ON THE VENTRICULAR CATHETER AND THE PERITONEAL CATHETER. THE INSTRUCTIONS FOR USE CAUTIONS, ¿SHUNT OBSTRUCTION MAY OCCUR IN ANY COMPONENT OF THE SHUNT SYSTEM. THE VENTRICULAR CATHETER MAY BECOME OCCLUDED BY PARTICULATE MATTER (E.G. BLOOD CLOTS, BRAIN FRAGMENTS, AND BACTERIAL COLONIZATION), BY INVESTMENT OF THE CATHETER TIP IN CHOROID PLEXUS, BY EMBEDDING OF THE CATHETER IN BRAIN TISSUE, OR BY COAPTATION OF THE VENTRICULAR WALLS IN THE PRESENCE OF OVERDRAINAGE (¿SLIT VENTRICLES¿).¿ ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-OPERATIVE DRAINAGE TEST FOUND THAT THE DRAINAGE WAS NOT SMOOTH. THE ANTIMICROBIAL CATHETERS WERE REPLACED WITH ANOTHER VENTRICULAR AND CARDIAC/PERITONEAL CATHETER WHICH THEIR FUNCTION WAS NORMAL, AND THEN ANOTHER SET OF ANTIMICROBIAL CATHETERS WHICH THEIR FUNCTION WAS ALSO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170127 ARES ANTIBIOTIC-IMPREGNATED CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 95001 0009010741 00643169762664

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR