BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1689810 · Received May 12, 2010

    Report

    Report Number
    3005172759-2010-00006
    Event Type
    Injury
    Date Received
    May 12, 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 ANY PREDISPOSING ANATOMICAL DEFECT, INJURY HISTORY, OR OTHER FACTORS THAT MAY HAVE CONTRIBUTED TO THE INJURY. 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 APPROXIMATELY 6 MONTHS PRIOR TO ACCLARENT'S AWARENESS OF THIS EVENT. ACCLARENT BECAME AWARE OF THIS EVENT ON (B) (6) 2010. A PT HAD A CSF-LEAK IN THE FRONTAL SINUS AFTER A HYBRID CASE INVOLVING FESS, AS WELL AS BALLOON SINUPLASTY WITH A SOLO BALLOON CATHETER. THE INFORMATION PROVIDED STATED THAT THE SOLO BALLOON CATHETER WAS NOT PLACED WITH AN ACCLARENT GUIDE CATHETER, BUT RATHER, THRU A SUCTION DEVICE, WITHOUT THE GUIDANCE OF A GUIDEWIRE. UPON NOTING THE CSF LEAK, THE PT WAS HOSPITALIZED. RESOLUTION OCCURRED 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 Hospitalization