BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER

    MDR report key: 3163084 · Received May 30, 2013

    Report

    Report Number
    3005172759-2013-00023
    Event Type
    Other
    Date Received
    May 30, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFORMATION. VP OF MEDICAL AFFAIRS CONCLUDED THAT THE TRANSIT SELF LIMITED PRESEPTAL EYELID SWELLING OCCURING DURING IRRIGATION OF THE MAXILLARY SINUS USING THE ACCLARENT VORTEX 2 DESCRIBED BY THE SURGEON IS PROBABLY RELATED TO THE ACCLARENT VORTEX 2 DEVICE. 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)(4) 2013 OF A DOMESTIC EVENT THAT OCCURRED ON (B)(6) 2013 DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE SURGEON PERFORMED A SEPTOPLASTY, INFERIOR TURBINATE REDUCTION, AND SINUS SURGERY CONSISTING OF BILATERAL ANTERIOR ETHMOIDECTOMY USING A MICROSHAVER, BILATERAL MAXILLARY AND SPHENOID BALLOON SINUPLASTY USING THE ACCLARENT SPIN DEVICE WITH VORTEX 2 IRRIGATION. THE SURGEON REPORTED THERE WAS NO DIFFICULTY ACCESSING AND DILATING AND IRRIGATING LEFT MAXILLARY SINUS. AFTER APPROXIMATELY 10 CC OF SALINE IRRIGATION WAS INSTALLED IN THE RIGHT MAXILLARY WITH THE ACCLARENT VORTEX 2 AND THE SURGEON NOTED A SMALL AMOUNT OF RIGHT LOWER EYELID SWELLING. HE STOPPED THE IRRIGATION AND APPROXIMATELY 10 MINUTES LATER, THE EYE LID SWELLING HAD COMPLETELY RESOLVED. NO MEDICAL TREATMENT WAS NEEDED AND NO SURGICAL INTERVENTION. THE SURGEON STATED THE EYELID SWELLING WAS NOT LIKELY PRESEPTAL SWELLING. THERE WAS NO VISUAL CHANGE IN THE RECOVERY ROOM. THE PATIENT WAS DISCHARGED. THE SURGEON REPORTED THAT THE PATIENT FELT THERE WAS SOME BLURRING OF VISION. THE PATIENT WAS SEEN BY AN OPHTHALMOLOGIST AND HE CONCLUDED THAT NOW EYELID SWELLING AND NO VISUAL CHANGE. THE BLURRING SUBSIDED OVER THE 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239251 RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER IRRIGATION CATHETER LRC ACCLARENT, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other ACCLARENT SPIN DEVICE| MICROSHAVER