BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA SOLO PRO BALLOON CATHTER

    MDR report key: 3177569 · Received June 10, 2013

    Report

    Report Number
    3005172759-2013-00025
    Event Type
    Other
    Date Received
    June 10, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ACCLARENT
    Product Code
    LRC
    PMA / PMN Number
    K061903
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFORMATION. THE PRESEPTAL ORBITAL SWELLING OCCURRED AT THE TIME OF THE IRRIGATION USING AN OLIVE TIPPED SUCTION. THE EYELID SWELLING MOST LIKELY OCCURRED FROM A DEHISCENCE IN THE LAMINA PAPYRECEA. THE VP OF MEDICAL AFFAIRS CONCLUDED THAT WITH THE INFORMATION PROVIDED IT IS IMPOSSIBLE TO SAY WHETHER THE DEHISCENCE OCCURRED FROM THE BALL TIPPED PROBE, ACCLARENT BALLOON DILATION OR FROM THE USE OF THE OLIVE TIPPED SUCTION. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, 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. THE SURGEON PERFORMED A BILATERAL MAXILLARY BALLOON SINUPLASTY ON A (B)(6) PT USING THE ACCLARENT SOLO PRO 5MM BALLOON ON (B)(6) 2013. THE SURGEON REPORTED EASY ACCESS OF THE MAXILLARY SINUS WITH THE ACCLARENT LUMA WIRE AND THE SOLO PRO BALLOON WAS INFLATED TWICE. AFTER REMOVING THE GUIDE WIRE AND BALLOON WAS INFLATED TWICE. AFTER REMOVING THE GUIDE WIRE AND BALLOON, THE SURGEON INSERTED A SMALL OLIVE TIPPED CURVED SUCTION INTO THE INFUNDIBULUM NEAR THE DILATED OSTIA TO ASPIRATE ANY MUCOUS. THE SURGEON THEN USED THE OLIVE TIPPED SUCTION TO INSTALL SALINE TO IRRIGATE THE SINUS. AS THIS WAS DONE, THE SURGEON NOTED PRESEPTAL SWELLING OF THE LOWER EYELID. SHE STOPPED THE IRRIGATION AND INSPECTED THE REGION WITH AN ENDOSCOPE. A SMALL BONY FRAGMENT WAS SEEN AND REMOVED EXPOSING THE PERIORBITA BUT NO ORBITAL FAT WAS SEEN. THE SURGEON ASKED AN OPHTHALMOLOGY COLLEAGUE TO EXAM THE PT AND THE INTRAOCULAR PRESSURES AND RETINAL EXAMINATION WERE NORMAL. THE SURGEON PROCEEDED AND COMPLETED THE RIGHT SIDE WITHOUT DIFFICULTY. BY THE COMPLETION OF THE RIGHT SIDE (APPROXIMATELY 10 MINUTES), THE LEFT EYELID SWELLING HAD RESOLVED. IN THE POST OPERATIVE RECOVERY AREA, THE VISION AND EYE REMAINED NORMAL. THE SURGEON SAW THE PT THE FOLLOWING DAY AND THERE WAS NO SWELLING, BRUISING OR VISUAL CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261706 RELIEVA SOLO PRO BALLOON CATHTER SOLO PRO SINUS BALLOON CATHETER LRC ACCLARENT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other ACCLARENT LUMA WIRE, OLIVE TIPPED SUCTION