BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA ULTIRRA SINUS BALLOON CATHETER

    MDR report key: 3229847 · Received July 10, 2013

    Report

    Report Number
    3005172759-2013-00027
    Event Type
    Other
    Date Received
    July 10, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ACCLARENT
    Product Code
    LRC
    PMA / PMN Number
    K111254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED BY THE NURSE, VP OF MEDICAL AFFAIRS CONCLUDED THAT PRESEPTAL ORBITAL SWELLING OCCURRED DURING THE USE OF THE ACCLARENT ULTIRRA BALLOON TECHNOLOGY. THE CLINICAL COURSE OF THE ORBITAL SWELLING WAS SELF LIMITED. THERE WAS NO PERMANENT OR SERIOUS INJURY. THERE WAS NO MALFUNCTION OF THE ACCLARENT DEVICES. PRECAUTIONARY CONSULTATION WAS OBTAINED BY THE OPERATING SURGEON AND ONLY SYMPTOMATIC TREATMENT WITH ICED COMPRESSES INITIATED. VP OF MEDICAL AFFAIRS INDICATED THAT THE ACCLARENT DEVICE POTENTIALLY CONTRIBUTED TO THE ORBITAL SWELLING. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVAL, 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. A (B)(6) YEAR OLD FEMALE WITH CHRONIC SINUSITIS WHO NEVER HAD SINUS SURGERY BEFORE. A SEPTOPLASTY, INFERIOR TURBINATE REDUCTION AND BALLOON SINUPLASTY (BSP) BILATERALLY OF THE FRONTAL, SPHENOID AND MAXILLARY SINUSES WAS PERFORMED UNDER GENERAL ANESTHESIA. PER THE RISK MANAGER, THERE WAS NO ETHMOIDECTOMY PERFORMED OR USE OF THE MICROSHAVER. THE ACCLARENT ULTIRRA BALLOON WAS USED (SIZE UNK) ALONG WITH THE ACCLARENT FRONTAL, SPHENOID AND MAXILLARY GUIDES AND LUMA GUIDEWIRE. IRRIGATION WAS PERFORMED ON ALL OF THE SINUSES USING AN UNK QUANTITY OF SALINE. AT THE TIME THE PT WAS EMERGING FROM ANESTHESIA, "VERY MILD SWELLING" OF THE RIGHT EYELID WAS NOTED. AN OPHTHALMOLOGIST WAS CALLED IN TO EXAMINE THE EYE AND FOUND NO ABNORMALITY AND DETERMINED THE SWELLING WAS MINIMAL AND REQUIRED NO INTERVENTION. ICED COMPRESSES WERE PLACED UPON THE EYE IN THE RECOVERY ROOM. UPON COMPLETE RECOVERY FROM ANESTHESIA, THERE WERE NO VISUAL CHANGES. THE PT WAS DISCHARGED. BY THE FOLLOWING DAY, ALL OF THE SWELLING RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316213 RELIEVA ULTIRRA SINUS BALLOON CATHETER SINUS BALLOON CATHETER LRC ACCLARENT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other