BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA SPIN SINUPLASTY SYSTEM

    MDR report key: 5354425 · Received January 8, 2016

    Report

    Report Number
    3005172759-2016-00002
    Event Type
    Injury
    Date Received
    January 8, 2016
    Date of Event
    December 8, 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
    NC, 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 REMOVAL OF THE POLYP USING THE SHAVER BLADE. 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): UNKNOWN BRAND OF RIGID SEEKER, BACK-BITER, AND SHAVER USED DURING THE SAME PROCEDURE ON (B)(6) 2015.

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED OF AN EVENT WHICH OCCURRED DURING A PROCEDURE IN WHICH A RELIEVAPIN BALLOON SINUPLASTY SYSTEM WAS USED. THE HYBRID PROCEDURE PERFORMED ON (B)(6) 2015 INCLUDED BALLOON SINUPLASTY (BSP) ALONG WITH AN ETHMOIDECTOMY, POLYPECTOMY, AND A MAXILLARY ANTROSTOMY. A RIGID SEEKER, BACK-BITER, AND A SHAVER WERE SAID TO HAVE BEEN USED IN ADDITION TO THE ACCLARENT PRODUCTS. THE BSP PORTION OF THE PROCEDURE WAS SAID TO HAVE BEEN COMPLETED AND THEN THE SHAVER WAS USED TO REMOVE A POLYP. SOMETIME THEREAFTER, A CSF (CEREBROSPINAL FLUID) LEAK WAS NOTICED, AND THE AREA WAS PACKED WITH SURGICELL. UPON THE COMPLETION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS NOTED TO HAVE BEEN NORMAL WITH NO REPORTED NEUROLOGIC DEFICITS. IT IS NOT KNOWN IF THE PATIENT REQUIRED ANY FURTHER INTERVENTION OR HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12672 RELIEVA SPIN SINUPLASTY SYSTEM INSTRUMENT, ENT MANUAL SURGICAL LRC ACCLARENT, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R