BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER

    MDR report key: 3350070 · Received September 9, 2013

    Report

    Report Number
    3005172759-2013-00031
    Event Type
    Other
    Date Received
    September 9, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 14, 2013
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL AFFAIRS DISCUSSED THIS EVENT WITH THE SURGEON ON (B)(4) 2013 AND HE STATED THAT FUNGAL SINUS DISEASE IS KNOWN TO ERODE AND DEMINERALIZE THE THIN BONY SINUS WALLS. THERE WAS CLINICAL PRESENCE OF EYE SWELLING AND CT PRESENCE OF SALINE WITHIN THE ORBIT ALONG WITH THE CT DESCRIBED BONY DEHISCENCE OF THE LAMINA PAPYRACEA. MEDICAL AFFAIRS INDICATED THAT THE VORTEX IRRIGATING CATHETER WAS NOT USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE WHICH DISCUSS THE USE AND PREPARATION OF THE RELIEVA SINUS GUIDE AS PART OF THE USE. THE VORTEX IRRIGATING CATHETER WAS USED WITHOUT THE SINUS GUIDE BUT RATHER WITH AN OLIVE TIPPED SUCTION CATHETER. WITH THE INFO PROVIDED, MEDICAL AFFAIRS CONCLUDED THAT THERE IS NOT ENOUGH TO SAY THE ACCLARENT VORTEX IRRIGATING DEVICE CONTRIBUTED TO THE DEHISCENCE THAT PERMITTED THE SALINE TO ENTER THE ORBIT. 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 A DOMESTIC EVENT THAT OCCURRED ON (B)(6) 2013 DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. AFTER COMPLETING ENDOSCOPIC SINUS SURGERY WITH REMOVAL OF POLYPS UTILIZING TRADITIONAL SINUS RIGID INSTRUMENTS, THE SURGEON UTILIZED ABOUT 220 CC OF SALINE VIA THE VORTEX CATHETER IN THE FRONTAL SINUS AND HAD NO DIFFICULTY. THE MAXILLARY SINUS WAS ALSO IRRIGATED USING ABOUT 220-260 CC OF SALINE INSTILLED THROUGH THE ACCLARENT VORTEX CATHETER INSERTED THROUGH AN OLIVE TIPPED CURVED SUCTION. AFTER THE SURGERY WAS COMPLETED AND THE PT WAS EMERGING FROM ANESTHESIA, THE EYE WAS NOTED TO SWELL. INTRAVENOUS STEROIDS AND A DIURETIC, MANNITOL, WERE GIVEN. THE PT WAS TAKEN TO THE RECOVERY AREA BY WHICH TIME THE SWELLING HAD LESSENED MARKEDLY. AN OPHTHALMOLOGIST WAS CALLED AND THE EVALUATION SHOWED NO CHANGE IN EYE MOVEMENT OR VISION. A COMPUTED TOMOGRAPHIC (CT) SCAN OF THE SINUSES SHOWED FLUID WITHIN THE ORBIT THAT THE RADIOLOGIST FELT WAS MORE THAN LIKELY SALINE RATHER THAN BLOOD. ALSO, THE CT SCAN REVEALED A SMALL TRAP DOOR BONY DEFECT. DR (B)(6) WAS UNCERTAIN AS TO WHETHER THIS WAS PREOPERATIVE AND OCCURRED FROM THE EXTENSIVE FUNGAL INFECTION, PREVIOUS SURGERY OR THE PRESENT SURGICAL PROCEDURE. HOWEVER, HE FELT THERE WAS A DEHISCENCE WITHIN THE LAMINA PAPYRACEA FROM THE FUNGAL DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445907 RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER IRRIGATION CATHETER LRC ACCLARENT, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DIURETIC MANNITOL| INTRAVENOUS STEROIDS AND| TRADITIONAL SINUS RIGID INSTRUMENTS| OLIVE TIPPED CURVED SUCTION