BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA ULTIRRA SINUS BALLOON CATHETER

    MDR report key: 3830172 · Received May 9, 2014

    Report

    Report Number
    3005172759-2014-00010
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K111254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP WAS RETRIEVED FROM PATIENT AT THE TIME OF SURGERY. THERE WAS NO INJURY TO THE TISSUE FROM TIP DETACHMENT. 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) 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 EXPERIENCED DIFFICULTY ACCESSING THE SINUS WHILE USING ULTIRRA BALLOON CATHETER WITH MAXILLARY GUIDE (110) DUE TO TIGHT INFUNDIBULUM. DURING THE PROCEDURE, THE ULTIRRA CATHETER TIP DETACHED COMPLETELY IN THE PATIENT'S NASAL CAVITY. AN UNKNOWN INSTRUMENT WAS USED TO RETRIEVE THE TIP. THERE WAS NO PATIENT INJURY DUE TO TIP DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281107 RELIEVA ULTIRRA SINUS BALLOON CATHETER SINUS BALLOON CATHETER LRC ACCLARENT, INC. NA 130912C-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCLARENT MAXILARY GUIDE, 110