BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA FLEX SINUS GUIDE CATHETER

    MDR report key: 2904691 · Received December 3, 2012

    Report

    Report Number
    3005172759-2012-00044
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    August 3, 2012
    Report Date
    August 3, 2012
    Manufacturer
    ACCLARENT
    Product Code
    LRC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADD'L INFO. THE SURGEON STATED THAT THE ACCLARENT TECHNOLOGY PERFORMED WELL. SHE BELIEVED THAT THE FRACTURE IN THE TIP OF THE GUIDE DEVICE WAS CAUSED BY THE SHARP BONE SPICULES. THERE WAS NO ADD'L INTERVENTION TO THE PT AND NO ADD'L CARE PROVIDED BECAUSE OF THIS OCCURRENCE. THERE HAS NOT BEEN ANY ADVERSE EVENT REPORTED DUE TO THIS MALFUNCTION AND PROBABILITY OF ANY POTENTIAL ADVERSE EVENT IS HIGHLY REMOTE. HENCE, THIS MALFUNCTION WAS NOT INITIALLY CONSIDERED AS A REPORTABLE EVENT, HOWEVER, AFTER RE-EVAL ON (B)(4) 2012, THE ORGANIZATION DECIDED TO REPORT IT IS ABUNDANCE OF CAUTION. ACCLARENT ATTEMPTED TO RETRIEVE THE DEVICE FOR FAILURE ANALYSIS, BUT THE DEVICE IS UNAVAILABLE FOR RETURN. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ACCLARENT WAS NOTIFIED ON (B)(6) 2012 OF A DOMESTIC EVENT THAT OCCURRED ON (B)(6), 2012 DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE SURGEON STATED THAT UPON REMOVING THE ACCLARENT FRONTAL SINUS GUIDE, A BLUE TIP PORTION WAS SEEN TO HAVE CRACKED AND A FRAGMENT WAS MISSING. THE SURGEON LOOKED INTO THE NOSE AND SAW THE FRAGMENT OF THE GUIDE IN THE FRONTAL OUTFLOW AND REMOVED IT ENTIRELY. POST OPERATIVELY, THE PT DID WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA FLEX SINUS GUIDE CATHETER FLEX GUIDE CATHETER LRC ACCLARENT F70 120503G-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR BALLOON| ACCLARENT LUMA GUIDE WIRE