BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROSENSOR VENTRICULAR CATHETER KIT

    MDR report key: 2133364 · Received June 16, 2011

    Report

    Report Number
    1226348-2011-00214
    Event Type
    Death
    Date Received
    June 16, 2011
    Date of Event
    March 12, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    K991222
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON REVIEW OF THE CONFIGURATION OF THE (B)(4) DEVICE, IT WAS NOTED THAT THE "DEPTH MARKINGS" ARE PLACED ON THE CATHETER, WHICH WOULD PROVIDE AN INDICATION OF THE DEPTH TO WHICH THE CATHETER/SENSOR WAS PLACED. THUS, THE CUSTOMER'S STATED CONCERNS ARE NOT FULLY UNDERSTOOD RELATIVE TO THIS DEVICE. FURTHER INFORMATION IS NEEDED TO ASSURE A CLEAR UNDERSTANDING OF THE REPORTED DEVICE. IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED, THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOME AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY, A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT PATIENT ICP CONTINUED TO RISE AFTER INTRACRANIAL DEVICE WAS INSERTED WITH WHAT APPEARED TO BE WITHOUT COMPLICATION. THE PATIENT WAS FOUND TO HAVE DILATED PUPILS AND TAKEN FOR A CT SCAN OF HER HEAD ABOUT 2 HOURS AFTER WIRE INSERTION. THE SCAN REVEALED A BLEED IN THE BASAL GANGLION AND BLOOD IN THE VENTRICLES. THERE WAS NO BLOOD ALONG THE TRACT OF THE WIRE. THE WIRE CAN BE SEEN AS FAR DOWN AS THE THIRD VENTRICLE DESPITE CAREFUL INSERTION TO WHAT WAS THOUGHT TO BE 2-3CM AT MOST. IT WAS REPORTED THAT THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSENSOR VENTRICULAR CATHETER KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| R