BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA ULTIRRA SINUS BALLOON CATHETER

    MDR report key: 3116110 · Received May 10, 2013

    Report

    Report Number
    3005172759-2013-00019
    Event Type
    Other
    Date Received
    May 10, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ACCLARENT
    Product Code
    LRC
    PMA / PMN Number
    K111254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED BY THE SURGEON, VP OF MEDICAL AFFAIRS CONCLUDED THAT THE ACCLARENT RELIEVA ULTIRRA BALLOON MOST LIKELY WAS RELATED TO THE EYE SWELLING. THE RAPID RESOLUTION AND LACK OF ANY OTHER EYE SYMPTOMS SPEAK TO THE SWELLING BE OF PRESEPTAL LOCATION. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNKNOWN. 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. A (B)(6) FEMALE PATIENT WHO WAS BLIND IN HER LEFT EYE UNDERWENT LEFT FRONTAL BALLOON SINUPLASTY UTILIZING ACCLARENT 7X24MM RELIEVA ULTIRRA BALLOON. AS THE SALINE WAS BEING INSTILLED, THE PATIENT MOVED SLIGHTLY AND THE SURGEON NOTED SOME RIGHT EYE SWELLING. HE IMMEDIATELY TERMINATED THE PROCEDURE. AN OPHTHALMOLOGIST EXAMINED THE PATIENT AND FOUND NORMAL INTRAOCULAR PRESSURE. INTRAOPERATIVE DECADRON AND CEFTRIAXONE WERE GIVEN INTRAVENOUSLY. THE PATIENT WAS AWAKENED AND THE VISION WAS INTACT WITH NO CHANGE. THE SWELLING QUICKLY RESOLVED. THE PATIENT WAS KEPT IN THE HOSPITAL FOR OVERNIGHT OBSERVATION AND RECEIVED ADDITIONAL INTRAVENOUS STEROIDS AND ANTIBIOTICS. SHE WAS DISCHARGED THE NEXT MORNING WITH NO EYE SWELLING AND NO VISION CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208202 RELIEVA ULTIRRA SINUS BALLOON CATHETER SINUS BALLOON CATHETER LRC ACCLARENT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O CEFTRIAZONE GIVEN INTRAVENOUSLY| INTRAOPERATIVE DECADRON GIVEN INTRAVENOUSLY