BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT ICP MONITORING KIT

    MDR report key: 4824507 · Received June 4, 2015

    Report

    Report Number
    2023988-2015-00014
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K914735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 07/15/2015. THE INVESTIGATION INCLUDED: DHR REVIEW, REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS, VISUAL. RESULTS: A REVIEW OF BATCH HISTORY RECORD INDICATES THAT THE CATHETER MET REQUIREMENTS BEFORE RELEASED TO FINISHED GOODS. COMPLAINT HISTORY, MODEL 110-4XX FROM JUNE 2014 THROUGH MAY 2015 REVIEWED, THERE WERE NINE OTHER COMPLAINTS THAT HAD AN ISSUE AND ONE OF THEM WAS CONFIRMED. THE FAILURE PERCENTAGE RATE FOR THE REPORTED INCIDENT IS 0.003%. THE CATHETER WAS CONNECTED TO TEST MONITOR 420-6, (CAL DUE JULY 2015), AFTER THE SYSTEM SELF-CHECK DELAYED, THE MONITOR DISPLAYED AN INITIAL READING OF 8MMHG. THE CATHETER WAS ZERO-BALANCED, AND TESTED. THE CATHETER WAS CONNECTED TO TEST MONITOR MPW-1 C-1999 (CAL DUE 03 MARCH 2016), AFTER THE SYSTEM SELF-CHECK DELAYED, THE MONITOR DISPLAYED AN INITIAL READING OF 1MMHG. THE CATHETER WAS CONNECTED TO CAM02 MONITOR SERIAL NUMBER (B)(4), CAL DUE JUNE 2016, AFTER THE SYSTEM SELF-CHECK, THE MONITOR DISPLAYED 0MMHG. CONCLUSION: THE REPORTED CUSTOMER COMPLAINT IS NOT VERIFIED. THE CATHETER WAS CONNECTED TO A TEST MONITOR AND AFTER A SELF-CHECK DELAY, THE MONITOR DISPLAYED AN INITIAL READING AND THE CATHETER WAS ZEROED, FUNCTIONALLY TESTED AND IT MET ALL FUNCTIONAL TEST CRITERIA.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF 2 MICROVENTRICULAR CATHETERS (1104HM) THAT WERE BEING PREPARED FOR USE WITH A CAM02 ON A PT FROM THE SAME FACILITY. CROSS REF WITH MFR. REPORT #: 2023988-2015-00013 (PR 128717). IT WAS REPORTED THAT A 1104HM MICROVENTRICULAR BOLT ICP (INTRACRANIAL PRESSURE) MONITORING KIT MALFUNCTIONED. THE EVENT WAS DESCRIBED AS FOLLOWS, "THE PHYSICIAN COULD NOT GET CAMINO TO "RECOGNIZE CATHETER" TO ZERO IT. THE CATHETER WAS NEVER INSERTED INTO THE PTS' CRANIUM. WHEN THE QUESTION WAS ASKED, "DID THE PT INCUR ANY INJURY AS A RESULT OF THIS EVENT? THE NURSE ANSWERED "ICP CATHETER WAS NEVER INSERTED INTO PT." THE INTEGRA LIFESCIENCES REP EXAMINED THE MACHINE AND WAS ABLE TO USE HER TEST CATHETER AND THE MACHINE WAS ABLE TO RECOGNIZE. BOTH CATHETERS THAT THE PHYSICIAN COULD NOT ZERO WERE REATTACHED TO THE CAMINO CABLE AND BOTH, AT THAT TIME, WERE RECOGNIZED WHEN REATTACHED TO CAMINO. CALL PLACED TO CLINICAL SUPPORT CONCLUSION WAS PROBABLY CABLE WAS NOT FULLY CONNECTED TO CAMINO MACHINE, THEREFORE, IT WAS UNABLE TO RECOGNIZE ICP CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363574 MICRO VENTRICULAR BOLT ICP MONITORING KIT NONE GWM INTEGRA NEUROSCIENCES CA/USA 305000273592

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR