BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR CATH. ACCESS KIT (LCAK)

    MDR report key: 3871649 · Received April 16, 2014

    Report

    Report Number
    9612007-2014-00012
    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 EVALUATION. IT WAS REPORTED THAT ONLY THE GUIDEWIRE WILL BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS REGARDING 910121 - LUMBAR CATH. ACCESS. KIT (LCAK) (SAME PATIENT, SAME PROCEDURE, SIMILAR PRODUCT PROBLEM, SAME PRODUCT ID, DIFFERENT LOT NUMBERS). THIS REPORT IS IN REGARDS TO THE SECOND LCAK KIT USED. IT WAS REPORTED THAT THE GUIDE WIRE FROM THE FIRST LCAK WOULD NOT ADVANCED 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233613 LUMBAR CATH. ACCESS KIT (LCAK) EXTERNAL DRAINAGE ACCESSORIES JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 182775

    Patients

    Seq Age Sex Outcome Treatment
    1