BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA ULTIRRA SINUS BALLOON CATHETER

    MDR report key: 3958612 · Received May 14, 2014

    Report

    Report Number
    3005172759-2014-00011
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K111254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT DID NOT INCLUDE INFO TO INDICATE THE BALLOON WAS MISSING FROM THE CATHETER. THE DEVICE EVAL PERFORMED UPON RECEIPT OF THE DEVICE CONFIRMED THE BALLOON WAS SEPARATED FROM THE CATHETER. PER SALES REP, THERE WAS NO PIECE OF THE BALLOON LEFT INSIDE THE PT'S BODY. IT IS SUSPECTED THAT THE DAMAGE COULD BE THE RESULT OF EXCESSIVELY AGGRESSIVE USE BY THE PHYSICIAN BEYOND WHAT WAS DESIGNED INTO THE DEVICE. 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) 2014 OF A DOMESTIC EVENT THAT OCCURRED ON (B)(6) 2014 DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE PHYSICIAN OPENED AN 7X24 ULTIRRA BALLOON CATHETER AND ATTEMPTED TO ADVANCE INTO A GUIDE CATHETER (M70). THE BALLOON CATHETER WOULD NOT ADVANCE INTO THE GUIDE. THE PHYSICIAN OPENED ANOTHER GUIDE CATHETER (M110) AND IT WORKED FINE. ACCLARENT RECEIVED THE RETURN ULTIRRA BALLOON CATHETER AND GUIDE CATHETER ON (B)(6) 2013 AND PERFORMED INVESTIGATION ON (B)(6) 2014. THE RETURN ULTIRRA BALLOON CATHETER WAS NOTED TO HAVE MISSING THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288717 RELIEVA ULTIRRA SINUS BALLOON CATHETER SINUS BALLOON CATHETER LRC ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK