BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR CATHETER ACCESSORY KIT (LCAK)

    MDR report key: 800472 · Received December 7, 2004

    Report

    Report Number
    9612007-2004-00064
    Event Type
    Malfunction
    Date Received
    December 7, 2004
    Date of Event
    October 29, 2004
    Report Date
    December 7, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IN 2004, THE NEUROSURGEON PLACED A LUMBAR DRAIN BY PLACING THE LUMBAR CATHETER INTO THE LUMBAR SUBARACHNOID SPACE. WHILE TRYING TO MANIPULATE OR PULL BACK ON THE CATHETER, WITH THE TOUHY NEEDLE IN PLACE, THE TOUHY NEEDLE SHEARED THE CATHETER. THE TIP OF THE CATHETER WAS LEFT IN THE LUMBAR SUBARACHNOID SPACE. IT IS UNKNOWN HOW MUCH (THE LENGTH OF THE CATHETER) WAS LEFT IN THE PT. AN ATTEMPT WAS MADE TO REMOVE THE BROKEN CATHETER TIP, BUT WAS UNSUCCESSFUL. THE NEUROLOGIST WAS CONTACTED AND ADVISED TO LEAVE THE BROKEN TIP IN PLACE. THIS FACILITY HAS BEEN USING THIS DEVICE FOR TEN YEARS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SINCE THE CORRECT PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED BY THE SALES REPRESENTATIVE, A REVIEW OF THE ACCOUNTS PURCHASE RECORDS WAS CONDUCTED FOR YEAR 2004. THIS ACCOUNT PURCHASED (4 QUANTITY) 910-120A LOT NUMBER 0125459, (4 QUANTITY) 910-120A FROM LOT NUMBER 0125007, AND (2 QUANTITY) 910-120A FROM LOT NUMBER 0127847. THIS KIT CONTAINS A 80CM LUMBAR CATHETER 910-121 AND THE EXTERNAL DRAINAGE SET CATALOG NUMBER 910-110. A COPY OF THE USER VOLUNTARY MEDWATCH REPORT WAS REC'D ON NOVEMBER 19, 2004 VIA FAX. THE USER INDICATES THE LUMBAR DRAINAGE CATHETER (910-121) SHEARED OFF IN THE PT AND THE NEUROSURGEON WAS UNABLE TO RETRIEVE. THE NEUROSURGEON DECIDED TO LEAVE THE BROKEN CATHETER PIECE IN PLACE AND THE PT WAS PLACED ON PROPHYLACTIC ANTIOBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR CATHETER ACCESSORY KIT (LCAK) EXTERNAL DRAINAGE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *