BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIGUIDE BEAMPATH NEURO-L

    MDR report key: 1439458 · Received August 12, 2009

    Report

    Report Number
    3005350457-2009-00002
    Event Type
    Injury
    Date Received
    August 12, 2009
    Date of Event
    July 1, 2009
    Report Date
    July 14, 2009
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K070157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT SURGERY TO REMOVE A FORAMINAL MENINGIOMA LOCATED BETWEEN THE VERTEBRAL ARTERY AND THE BRAIN STEM. AN EXTENDED TRANSCONDYLAR APPROACH TO THE SKULL BASE REGION WAS PERFORMED. THE OMNIGUIDE BEAMPATH FIBER WAS USED SURGICALLY DISSECT THE TUMOR. IMMEDIATELY POST OP, A CT SCAN WAS OBTAINED SHOWING PNEUMOCEPHALUS IN BOTH THE SURGICAL LOCATION AT THE SKULL BASE AND SUPERIORLY, ANTERIOR TO THE FRONTAL LOBES. IN CRANIAL CASES IT IS NOT UNUSUAL FOR ACCUMULATION OF AIR (PNEUMOCEPHALUS) TO OCCUR DURING SURGERY. THESE USUALLY RESOLVE SPONTANEOUSLY POST OPERATIVELY. THE DR. DID NOT BELIEVE THAT THERE WAS A PATHWAY LEADING FROM THE SURGICAL SITE AND FRONTAL LOBE REGION. CT SCANS PERFORMED ON DAYS 1-4 POST-OPERATIVELY, DID NOT INDICATE A CHANGE IN PNEUMOCEPHALUS SIZE. NO TREATMENT WAS PROVIDED UNTIL DAY 4, WHEN THE DR. PLACED A SEP DRAIN AND REMOVED THE ENTRAPPED AIR. THE DR. NOTED THAT THE TUMOR COULD NOT HAVE BEEN REMOVED WITHOUT THE FIBER, BECAUSE OF ITS PROXIMITY TO CRITICAL NEURO-ANATOMICAL STRUCTURES. THERE WAS NO INDICATION THAT THE FIBER MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIGUIDE BEAMPATH NEURO-L CO2 WAVEGUIDE FIBER GEX OMNIGUIDE, INC. NEURO-L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention