BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER

    MDR report key: 4151913 · Received October 6, 2014

    Report

    Report Number
    3005172759-2014-00027
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ACCLARENT
    Product Code
    KAM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS DISCARDED BY THE USER FACILITY AND WAS NOT AVAILABLE FOR EVALUATION. REVIEW OF MANUFACTURING RECORDS ASSOCIATED WITH THE SUBJECT DEVICE DID NOT DETECT ANY ANOMALIES. THE PHYSICIAN REPORTED HAVING NO DIFFICULTIES IN USING THE ACCLARENT DEVICE DURING OR AFTER THE PROCEDURE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED, AND ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. SEE ALSO MDR 3005172759-2014-00028 FOR A RELATED REPORT.

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED OF AN EVENT THAT OCCURRED DURING A PROCEDURE IN WHICH AN RELIEVA SPIN BALLOON SINUPLASTY SYSTEM AND AN ACCLARENT VORTEX 2 IRRIGATION CATHETER DEVICE WERE USED. THE PHYSICIAN HAD DIFFICULTY ACCESSING THE RIGHT FRONTAL SINUS USING THE SPIN DEVICE AND USED AN UNIDENTIFIED FRONTAL SEEKER TO ACCESS THE SINUS. AFTER THE PHYSICIAN SUCCESSFULLY DILATED THE SINUS, THE PHYSICIAN BEGAN IRRIGATING THE RIGHT FRONTAL SINUS USING AN ACCLARENT VORTEX 2 IRRIGATION CATHETER. DURING IRRIGATION, THE PHYSICIAN OBSERVED ORBITAL FAT BULGING INTO THE RIGHT FRONTAL SINUS RECESS AND THE PATIENT'S RIGHT EYE SWELLING AND LEAKING SALINE. THE PHYSICIAN MADE AN INCISION INTO THE RIGHT EYELID TO REDUCE THE PRESSURE AND DRAIN THE EXCESS SALINE, AND CALLED FOR AN OPHTHALMIC SURGEON. THE OPHTHALMIC SURGEON TESTED THE PRESSURE IN THE PATIENT'S RIGHT EYE AND CONFIRMED TO BE NORMAL. THE PHYSICIAN THEN REMOVED A PORTION OF THE PROTRUDING ORBITAL FAT FROM THE NASAL CAVITY AND SUTURED UP THE INCISION MADE ON THE RIGHT EYELID. PATIENT WAS SAID TO BE FINE AFTER THE PROCEDURE. PATIENT FOLLOW UP OCCURRED THE FOLLOWING WEEK AND SHOWED THE PATIENT IS DOING WELL WITH NO FURTHER SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623084 RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER IRRIGATIION CATHETER KAM ACCLARENT NA 140108K-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention UNIDENTIFIED FRONTAL SEEKER