BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEX IRRIGATING CATHETER

    MDR report key: 3030579 · Received March 18, 2013

    Report

    Report Number
    3005172759-2013-00010
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFORMATION. THE SURGEON INDICATED THAT IRRIGATING CATHETER CAUSED A SMALL MUCOSAL TEAR AND IRRIGATING FLUID TRAVERSED INTO THE SOFT TISSUE. THE VP OF MEDICAL AFFAIRS CONCLUDED THAT THE EYE AND CHEEK SWELLING APPEARED TO COME FROM THE EXTRAVASATED IRRIGATION FLUID. THIS RESOLVED ON ITS OWN AND PRECAUTION WAS TAKEN TO OBTAIN AN OPTHALMAOLOGIC EXAMINATION AND OBSERVE AND KEEP THE PATIENT OVERNIGHT. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNKNOWN. 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 THAT OCCURRED ON (B)(6) 2013, DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WERE USED. AN ACCLARENT SPIN DEVICE WAS USED TO DILATE RIGHT MAXILLARY SINUS WITH NO DIFFICULTY. THE ACCLARENT VORTEX IRRIGATING CATHETER WAS USED TO ENTER THE DILATED MAXILLARY SINUS OSTIA. WHEN INITIATING IRRIGATION, THE OPERATING ROOM ASSISTANT SAID THAT THE FLUID WAS GOING VERY SLOWLY AND WAS MEETING RESISTANCE. THE IRRIGATING CATHETER WAS PULLED BACK AND THE IRRIGATING FLUID ENTERED THE SINUS MORE EASILY. THE RIGHT CHEEK AND EYELID WERE NOTED SWELL. THE IRRIGATION WAS STOPPED. THE ENDOSCOPE REVEALED A SMALL TEAR IN THE MUCOSA OF THE ROOF OF THE MAXILLARY SINUS. THE SURGEON ASKED FOR AN OPHTHALMOLOGIST TO THE OPERATION ROOM AND FOUND THE INTRAOCULAR PRESSURES NORMAL. WITHIN 10 MINUTES, THE EYELID SWELLING BEGAN TO DIMINISH. THE PATIENT WAS KEPT OVERNIGHT AND BY THE NEXT DAY, NEARLY ALL OF THE SWELLING WAS GONE. THERE WAS NEVER ANY VISION CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112047 VORTEX IRRIGATING CATHETER IRRIGATION CATHETER KAM ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization ACCLARENT CYCLOPS ENDOSCOPE