BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA SPIN SINUPLASTY SYSTEM

    MDR report key: 2987960 · Received February 25, 2013

    Report

    Report Number
    3005172759-2013-00005
    Event Type
    Other
    Date Received
    February 25, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ACCLARENT
    Product Code
    LRC
    PMA / PMN Number
    K111875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFO. VP OF MEDICAL AFFAIRS CONCLUDED THAT THE EYE SWELLING DID RESULT IN CAUTIOUS MANAGEMENT WITH ELECTIVE OVERNIGHT OBSERVATION, CT SCAN AND OPHTHALMOLOGIC EVALUATION. FROM THE INFO PROVIDED THE ACCLARENT DEVICES POTENTIALLY CONTRIBUTED TO THE EVENT OF EYELID SWELLING. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNK. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ACCLARENT WAS NOTIFIED ON (B)(6) 2013 OF AN EVENT DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WERE USED. THE PT UNDERWENT A SEPTOPLASTY, RIGHT INFERIOR TURBINATE REDUCTION WITH SHAVER, BILATERAL MAXILLARY BALLOON SINUPLASTY, AND LEFT FRONTAL RECESS BSP UNDER GENERAL ANESTHESIA. SEVERAL ATTEMPTS TO ACCESS THE LEFT FRONTAL RECESS WITH THE ACCLARENT LUMA WIRE WERE UNSUCCESSFUL. THE SURGEON DECIDED TO DILATE THE LEFT FRONTAL RECESS WITH ACCLARENT RELIEVA BALLOON. AFTER COMPLETING THE SURGERY AND WHILE INSERTING AN INJECTIBLE FOAM DRESSING, THE SURGEON NOTED LEFT EYELID SWELLING. DURING THE RECOVERY PERIOD, A DIAGNOSTIC CT SCAN SHOWED PRESEPTAL AIR IN THE EYELID WITH NO OBVIOUS TRAUMA TO THE PERIORBITAL TISSUES OR BONE. THERE WAS NO CHANGE IN VISION. AS A PRECAUTION, THE SURGEON ELECTED TO ADMIT THE PT OVERNIGHT FOR OBSERVATION AND THE OPHTHALMOLOGIST CONFIRMED NORMAL VISION. THE SWELLING HAD RESOLVED BY THE MORNING. THE SURGEON HAS SEEN THE PT POSTOPERATIVELY AND REPORTED THE PT HAS DONE WELL AND HAD NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79002 RELIEVA SPIN SINUPLASTY SYSTEM SPIN SINUS BALLOON CATHETER LRC ACCLARENT NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization UNKNOWN BRAND SHAVER| COTTLE ELEVATOR