BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA SPIN SINUPLASTY SYSTEM

    MDR report key: 3068092 · Received April 11, 2013

    Report

    Report Number
    3005172759-2013-00016
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ACCLARENT
    Product Code
    LRC
    PMA / PMN Number
    K111875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFO. BASED ON THE INFO PROVIDED BY THE ACCLARENT REP WHO ATTENDED THE CASE, VP OF MEDICAL AFFAIRS CONCLUDED THAT THE EYELID SWELLING WAS EXTREMELY TRANSIENT AND RESOLVED IMMEDIATELY BY SUCTIONING THE NASAL OR SINUS CAVITY. THERE IS NO EVIDENCE OF ANY SIGNIFICANT BREACH OF THE ORBIT. THERE WAS NO INTERVENTION OR ADDITIONAL TREATMENT. MOST PTS RECEIVING PREOPERATIVE STEROIDS WILL RECEIVE STEROIDS AFTER SURGERY. 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 PT HAD BALLOON SINUPLASTY OF THE MAXILLARY SINUSES WITHOUT ETHMOIDECTOMY WAS PERFORMED USING THE ACCLARENT SPIN DEVICE. A BALL PROBE WAS USED IN THE SINUS CAVITY. FOLLOWING THE DILATION, A STRAIGHT SUCTION WAS INSERTED INTO THE SINUS AND THE MAXILLARY SINUS WAS IRRIGATED. AS THE IRRIGATION WAS INSTILLED THROUGH THE SUCTION, THE LEFT EYELID WAS NOTED TO SWELL. FURTHER SUCTIONING OF THE SINUS SEEMED TO IMMEDIATELY RESOLVE THE SWELLING. THE RIGHT MAXILLARY SINUS WAS DILATED WITHOUT DIFFICULTY. AN ICE PACK WAS APPLIED TO THE LEFT EYE AND THE PT WAS SENT HOME ON PREDNISONE. THERE WERE NO VISUAL PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156009 RELIEVA SPIN SINUPLASTY SYSTEM SPIN SINUS BALLOON CATHETER LRC ACCLARENT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other A BALL PROBE| STRAIGHT SUCTION