BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA SPIN SINUPLASTY SYSTEM

    MDR report key: 2896237 · Received December 28, 2012

    Report

    Report Number
    3005172759-2012-00049
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ACCLARENT
    Product Code
    LRC
    PMA / PMN Number
    K111875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFO. THE SURGEON STATED THAT THE ACCLARENT DEVICES PERFORMED WITHOUT PROBLEM. BASED UPON THE INFO PROVIDED, HE BELIEVED THAT THE EYE SWELLING MAY HAD BEEN CAUSED BY THE VORTEX CATHETER TRACKED UNDER THE MUCOSA AND FLUID INSTILLED UNDER PRESSURE FROM THE SYRINGE TRACKED THOUGH A TINY BONY DEFECT ALREADY PRESENT OR ONE THAT OCCURRED FROM THE BALLOON SINUPLASTY. MICRO FRACTURES. THE SUBJECT DEVICE OF THIS REPORT WAS RETURNED ON (B)(4) 2012 FOR EVAL, AND THE RETURNED DEVICE FUNCTIONED PROPERLY AND NO DAMAGE WAS NOTED. 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) 2012 OF AN EVENT THAT OCCURRED ON (B)(6) 2012 DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WERE USED. AN ACCLARENT SPIN DEVICE WAS USED TO DILATE THE MAXILLARY SINUS. AFTER THE SUCCESSFUL DILATION, THE SURGICAL ASSISTANT BEGAN TO IRRIGATE WITH A 30CC SYRINGE OF SALINE USING ACCLARENT VORTEX 2 IRRIGATING CATHETER. THERE WAS RESISTANCE AND THE PHYSICIAN NOTED SOME EYE SWELLING. THE IRRIGATION WAS IMMEDIATELY STOPPED AND EYE MASSAGED. THE SWELLING IMMEDIATELY SUBSIDED. AN OPHTHALMOLOGIST EXAMINED THE PT AND FOUND NO ABNORMALITIES. THE PT'S VISION WAS NORMAL AND EYE MOVEMENT NORMAL. THE PT WAS CALLED TWICE DURING THE SEVERAL DAYS AFTER SURGERY AND HAD NO EYE COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA SPIN SINUPLASTY SYSTEM SPIN SINUS BALLOON CATHETER` LRC ACCLARENT NA 121002D

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening VORTEX 2 IRRIGATING CATHETER