BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA SPIN SINUPLASTY SYSTEM

    MDR report key: 5358592 · Received January 11, 2016

    Report

    Report Number
    3005172759-2016-00003
    Event Type
    Injury
    Date Received
    January 11, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 10, 2015
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K111875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AGE AND WEIGHT OF THE PATIENT ARE NOT KNOWN. THE ACCLARENT PRODUCTS USED DURING THE PROCEDURE WERE SAID TO HAVE FUNCTIONED AS NORMAL AND THE BSP PROCEDURE WAS COMPLETED AS PLANNED. THE PHYSICIAN NOTED THAT THE SUSPECTED CAUSE OF THE CSF (CEREBROSPINAL FLUID) LEAK WAS THE RIGID INSTRUMENTATION. NO ACCLARENT DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION AS THEY WERE DISCARDED BY THE USER FACILITY. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS REPORT, A SUPPLEMENTAL REPORT WILL BE FILED. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDE TREATMENT OF EVENT): RIGID INSTRUMENTS (UNKNOWN BRAND) AND THE MEDTRONIC STRAIGHT-SHOT SHAVER USED DURING THE SAME PROCEDURE ON (B)(6) 2015.

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED OF AN EVENT WHICH OCCURRED AFTER A PROCEDURE IN WHICH A RELIEVA SPIN BALLOON SINUPLASTY SYSTEM WAS USED. THE HYBRID FRONTAL SINUS REVISION SURGERY PERFORMED ON (B)(6) 2015, IN THE OR/ASC, INCLUDED A BALLOON SINUPLASTY (BSP). RIGID INSTRUMENTS OF AN UNKNOWN BRAND AND THE MEDTRONIC STRAIGHT-SHOT SHAVER WERE SAID TO HAVE BEEN USED IN ADDITION TO THE ACCLARENT PRODUCTS. A CT SCAN WAS ORDERED AT THE END OF THE BSP PROCEDURE AND A CSF (CEREBROSPINAL FLUID) LEAK WAS NOTICED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE LEAK WAS STOPPED WITH THE CREATION OF A FLAP IN THE ANATOMY. THE PATIENT'S CURRENT CONDITION IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18117 RELIEVA SPIN SINUPLASTY SYSTEM INSTRUMENT, ENT MANUAL SURGICAL LRC ACCLARENT, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R