BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1689811 · Received May 12, 2010

    Report

    Report Number
    3005172759-2010-00005
    Event Type
    Injury
    Date Received
    May 12, 2010
    Date of Event
    April 9, 2010
    Report Date
    May 7, 2010
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION AVAILABLE DID NOT MENTION WHETHER THE PT HAD A PREVIOUS HISTORY OF INJURY, OR ANY PRE-EXISTING ANATOMICAL DEFECTS. IT DID, HOWEVER, STATE THAT THE PT HAD A LONGER THAN NORMAL UNCINATE PROCESS, IN ADDITION TO A SMALL RIGHT FRONTAL SINUS IN RELATION TO THE LEFT FRONTAL SINUS. IT IS UNK WHAT OTHER SURGICAL INSTRUMENTS MAY HAVE BEEN USED TO PERFORM THE ETHMOIDECTOMY NOTED IN THE COMPLAINT REPORT. A REVIEW OF THE HISTORICAL TRENDING WAS PERFORMED FOR CSF LEAK, AND NO SIGNIFICANT TRENDS WERE NOTED. IN ADDITION, NO PRODUCT MALFUNCTION WAS NOTED. THE LOT INFORMATION WAS NOT AVAILABLE. NO DEVICE (S) WERE AVAILABLE FOR RETURN. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFORMATION AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN ONE PT. ACCLARENT WAS MADE AWARE OF THIS EVENT ON 4/12/2010. A PT HAD A CSF-LEAK IN THE RIGHT FRONTAL SINUS AFTER A HYBRID CASE INVOLVING FESS, AN ANTERIOR ETHMOIDECTOMY, AS WELL AS BALLOON SINUPLASTY. THE COMPLAINT INFORMATION NOTED PLACEMENT OF THE SOLO PRO BALLOON IN THE RIGHT FRONTAL SINUS APPEARED ODD. CONSEQUENTLY, THE SURGEON PERFORMED A CT SCAN, CONCLUDING THE GUIDEWIRE AND BALLOON WERE ADVANCED POSTERIOR TO THE FRONTAL SINUS. THE PT WAS TREATED WITH GEL FOAM AND GLUE TO RESOLVE THE LEAK. THE PT WAS PLACED WITH A LUMBAR DRAIN. NO EVIDENCE OF A PERSISTENT LEAK WAS NOTED SHORTLY THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE KAM ACCLARENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention