BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT DEVICE SPECIFIC/NO DEVICE MALFUNCTION

    MDR report key: 2232600 · Received August 25, 2011

    Report

    Report Number
    3005172759-2011-00008
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    August 23, 2011
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION WAS NOTED. ACCLARENT'S DEVICES WERE NOTED TO HAVE PERFORMED WITHOUT FAULT AND AS EXPECTED. THE DEVICES USED WERE NOT AVAILABLE FOR EVAL. NO LOT INFO WAS PROVIDED. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADD'L INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

    Description of Event or Problem · 1

    ACCLARENT WAS MADE AWARE OF AN EVENT ON (B)(6) 2011 INVOLVING A (B)(6) FEMALE WITH EXTENSIVE SINUS AND NASAL POLYPS CAUSING CHRONIC SINUSITIS. THE FOLLOWING CASE FEEDBACK WAS NOTED FROM DISCUSSION WITH THE ACTING PHYSICIAN: AN ACCLARENT RELIEVA BALLOON WAS INSERTED INTO THE RIGHT FRONTAL SINUS AND WAS DILATED. FOLLOWING SUCCESSFUL DILATION, ACCLARENT'S VORTEX IRRIGATING CATHETER WAS USED. UPON THE FOURTH IRRIGATION OF SALINE AT A LOW PRESSURE, A THICK DISCHARGE WAS NOTED TO COME FROM THE SINUS. AT THIS TIME, THE PHYSICIAN NOTED THAT THE PT'S RIGHT EYE APPEARED PROPTOTIC (CONDITION RESULTING IN FORWARD DISPLACEMENT). THE TONOMETRIC EYE PRESSURE WAS NOTED AS 60MM. A LATERAL CANTHOTOMY (INCISION NEAR THE EYELID TO RELIEVE PRESSURE) WAS PERFORMED AND THE PRESSURE CAME DOWN TO 30MM. THERE WAS NO CHANGE IN VISION AND NO DOUBLE VISION. HOSPITALIZATION WAS NOT REQUIRED. THE PT IS DOING WELL WITH GOOD HEALING OF THE SINUSES AND NO OPHTHALMOLOGIC PROBLEM. THE PHYSICIAN NOTED THAT THE ACCLARENT GUIDE, GUIDEWIRES, BALLOONS AND IRRIGATING CATHETER PERFORMED WITHOUT PROBLEM, AND THAT THE PROPTOSIS AND NEED FOR LATERAL CANTHOTOMY RELATED TO THE EXTENSIVE PATHOLOGY CAUSING BONE EROSION. THIS UNIQUE PT ANATOMY PERMITTED THE IRRIGATING FLUID TO TRACK FROM THE SINUS INTO THE ORBIT. THE PHYSICIAN NOTED THAT THIS WAS NOT DEVICE RELATED AND COULD HAVE OCCURRED WITH TRADITIONAL SURGERY. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ADDITIONAL INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT DEVICE SPECIFIC/NO DEVICE MALFUNCTION NA KAM NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention