BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR CATH. ACCESS. KIT (LCAK)

    MDR report key: 3871659 · Received April 16, 2014

    Report

    Report Number
    9612007-2014-00011
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    March 27, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K970658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS REGARDING 910121-LUMBAR CATH. ACCESS. KIT (LCAK) (SAME PT, SAME PROCEDURE, SIMILAR PRODUCT PROBLEM, SAME PRODUCT ID, DIFFERENT LOT NUMBERS). THIS REPORT IS IN REGARDS TO THE FIRST LCAK KIT USED. IT WAS REPORTED THAT THE GUIDE WIRE FROM THE FIRST LCAK WOULD NOT ADVANCE THROUGH THE LUMBAR CATHETER; IT KEPT GETTING STUCK. A SECOND SET OF LCAK WAS USED. THE GUIDEWIRE FROM THE SECOND LCAK GOT STUCK IN THE CATHETER. WHEN REMOVED WITH FORCE, IT WAS NOTICED THAT THE GUIDE WIRE WAS FRAYED. IT WAS REPORTED THAT THE CATHETER REMAINED IN PLACE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233619 LUMBAR CATH. ACCESS. KIT (LCAK) EXTERNAL DRAINAGE ACCESSORIES JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 183767

    Patients

    Seq Age Sex Outcome Treatment
    1