BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR CATHETER CLOSED TIP 80CM

    MDR report key: 725990 · Received June 8, 2006

    Report

    Report Number
    2648988-2006-00022
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Report Date
    June 7, 2006
    Manufacturer
    INTEGRA NEUROSCIENCES, PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TEN UNOPENED SAMPLES WERE RECEIVED FROM THE HOSP. AN INVESTIGATION SHOWS THE PRODUCTS COMPLY WITH ALL MANUFACTURING SPECS AND DEVICE HISTORY RECORD REQUIREMENTS. A FAILURE INVESTIGATION FINDS THAT THE PRODUCT FUNCTIONS AS DESIGNED WHEN THE PACKAGE INSERT INSTRUCTIONS ARE FOLLOWED. A SIMULATION AS TO THE CAUSE OF THE BUNCHING FINDS THAT THE GUIDEWIRE, IF COILED AROUND THE FINGERS TO IMPROVE THE HOLD OR GRIP, THE COILING ACTION ON THE GUIDEWIRE AFFECTS THE SMOOTH REMOVAL OF THE GUIDEWIRE FROM THE CATHETER BEING THE ROOT CAUSE OF THE BUNCHING/KINKING. THE BUNCHING THEN CAUSES THE CATHETER TO SHEAR AGAINST THE TOUHY NEEDLE WHEN EXCESSIVE FORCE IS APPLIED TO REMOVE THE BUNCHED CATHETER/GUIDEWIRE. UNCOILING THE GUIDEWIRE RESULTED IN A SMOOTH REMOVAL OF THE GUIDEWIRE. THE INVESTIGATION CONCLUDED THAT THE OCCURRENCE IS DUE TO SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    NEUROSURGEON (HIGHLY EXPERIENCED WITH LUMBAR CATHETER PLACEMENT) WAS ATTEMPTING TO PLACE A LUMBAR CATHETER AND THE GUIDEWIRE SEEMED TO BE TOO TIGHT INSIDE DIAMETER OF THE CATHETER CAUSING CATHETER TO "KINK," "BUNCH" AND TEAR LEAVING CATHETER TIP IN PT. THIS INCIDENT OCCURRED WITH LOT #1052792. WHILE REPORTING THIS INCIDENT, THE SURGEON REPORTED POSSIBLY 4 OTHER INCIDENTS FROM LAST WEEK WITH THE SAME RESULT. THE CATHETER BUNCHED AND THE TIP REMAINED IN THE PTS. NO ATTEMPTS WERE MADE TO RETRIEVE CATHETER TIPS FROM THE PTS. NEUROSURGEON OPENED A STERILE CATHETER TO DEMONSTRATE TO THE NEUROSPECIALIST HOW THE CATHETER KINKED. ADDITIONAL INFO WAS RECEIVED ON MAY 24, 2006: THERE WERE 2 OTHER INCIDENTS INVOLVING THIS DEVICE THAT WERE PREVIOUSLY NOT REPORTED. ALL 3 INCIDENTS INVOLVED DEVICES MANUFACTURED UNDER THE SAME LOT, IDENTIFIED AS 1052792. ALL 3 PTS ARE REPORTEDLY RECOVERING. THIS MEDICAL DEVICE REPORT IS LINKED WITH MEDICAL DEVICE REPORT NUMBERS 2648988-2006-00021 AND 2648988-2006-00023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR CATHETER CLOSED TIP 80CM EVD JXG INTEGRA NEUROSCIENCES, PR * 1052792

    Patients

    Seq Age Sex Outcome Treatment
    1 *