BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER

    MDR report key: 3445640 · Received October 25, 2013

    Report

    Report Number
    3005172759-2013-00035
    Event Type
    Other
    Date Received
    October 25, 2013
    Date of Event
    October 4, 2013
    Report Date
    October 4, 2013
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VP OF MEDICAL AFFAIRS DISCUSSED THIS EVENT WITH THE PHYSICIAN ON (B)(4) 2013. THE PHYSICIAN INDICATED THAT THE VORTEX 2 CATHETER TRACKED INTO THE MAXILLARY SINUS SUBMUCOSA PERMITTING THE ENTRANCE OF SALINE INTO THE SOFT TISSUE CREATING A PRESEPTAL ORBITAL SWELLING. VP OF MEDICAL AFFAIRS CONCLUDED THAT THE ACCLARENT VORTEX 2 IRRIGATION CATHETER DID CONTRIBUTE TO THE SELF LIMITED ORBITAL SWELLING AND THIS MINOR INJURY REQUIRED MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    ACCLARENT WAS NOTIFIED ON (B)(6) 2013 OF A DOMESTIC EVENT THAT OCCURRED ON (B)(6) 2013 DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE PHYSICIAN PERFORMED A BSP IN THE OPERATING UNDER GENERAL ANESTHESIA ON AN ADULT PT WHOSE MAXILLARY SINUS OUTFLOW WAS OBSTRUCTED BY A LARGE HALLER CELL. THE MAXILLARY SINUS WAS ACCESSED WITH A GUIDE WIRE AND CONFIRMATION OF THE LOCATION WAS ACHIEVED. BALLOON DILATION WAS ACCOMPLISHED WITHOUT DIFFICULTY. AN ACCLARENT VORTEX 2 CATHETER WAS INSERTED INTO THE MAXILLARY SINUS FOR IRRIGATION. THE PHYSICIAN REPORTED THAT THE IRRIGATING CATHETER WAS INSERTED FREELY AND NOT OVER GUIDEWIRE AND SOME RESISTANCE WAS MET. A FEW MILLILITERS OF SALINE WERE INSTILLED INTO THE MAXILLARY SINUS AND THERE WAS IMMEDIATE EYELID SWELLING. THE PHYSICIAN TERMINATED THE IRRIGATION AND WITHDRAW THE VORTEX 2 CATHETER. HE MESSAGED THE EYE AND WITHIN MINUTES THE EYE SWELLING DISAPPEARED. INTRAOCULAR PRESSURE WAS MEASURED AND WAS NORMAL. UPON AWAKENING THE PT AND NO CHANGE IN QUALITY OF VISION, DIPLOPIA, OR BLINDNESS. THE PHYSICIAN GAVE A PROPHYLACTIC DOSE OF INTRAVENOUS STEROIDS AND ASKED FOR AN OPHTHALMOLOGIST TO EXAMINE THE PT WHO FOUND NO ABNORMALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548372 RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER IRRIGATION CATHETER LRC ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention