BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 9733560 FUSION EM

    MDR report key: 8157805 · Received December 12, 2018

    Report

    Report Number
    1723170-2018-06170
    Event Type
    Injury
    Date Received
    December 12, 2018
    Date of Event
    August 22, 2018
    Report Date
    December 10, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. SAYAL, N. R., KEIDER, E., <(>&<)> KORKIGIAN, S. (2018). VISUALIZED ETHMOID ROOF CEREBROSPINAL FLUID LEAK DURING FRONTAL BALLOON SINUPLASTY. EAR, NOSE <(>&<)> THROAT JOURNAL, 97(8), E34-E38. DOI:10.1177/014556131809700807. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. UDI NOT AVAILABLE FOR THIS SYSTEM AT TIME OF FILING. THE DEVICE WAS NOT RETURNED, SO NO ANALYSIS WAS CONDUCTED. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION SAYAL, N. R., KEIDER, E., <(>&<)> KORKIGIAN, S. (2018). VISUALIZED ETHMOID ROOF CEREBROSPINAL FLUID LEAK DURING FRONTAL BALLOON SINUPLASTY. EAR, NOSE, THROAT JOURNAL, 97(8), E34-E38. DOI:10.1177/014556131809700807 ABSTRACT BALLOON SINUS DILATION (BSD) ISGENERALLY ACCEPTED AS A SAFE ALTERNATIVE TO TRADITIONAL SINUS SURGERY. IT IS A UNIQUE TECHNIQUE DESIGNED TO POTENTIALLY MINIMIZE COMPLICATIONS ASSOCIATED WITH TRADITIONAL FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). WE PRESENT A CASE IN WHICH A 65-YEAR-OLD MAN EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAK IN THE ETHMOID ROOF THAT WAS VISUALIZED INSTANTLY AFTER BALLOON DILATION IN A REVISION SINUS SURGERY. IN THIS CASE REPORT, WE DISCUSS THE CAUSES OF CSF LEAKS AND EXPLAIN IN DETAIL THE IMMEDIATE ENDOSCOPIC REPAIR WITH A COLLAGEN MATRIX. ALSO, LITERATURE IS REVIEWED ON THE SAFETY OF BSD VERSUS TRADITIONAL FESS. POSTOPERATIVELY, THE PATIENT HAS BEEN WITHOUT CSF LEAK AND REMAINS SYMPTOM FREE. CSF LEAK IS A RARE BUT MAJOR COMPLICATION DURING BOTH FESS AND BSD. AS BSD USE INCREASES, ITS COMPLICATION PROFILE WILL BECOME CLEARER WHEN USED ALONE, IN CONJUNCTION WITH FESS, AND/OR DURING REVISION SURGERY. ALTHOUGH BSD IS CONSIDERED A BENIGN PROCEDURE, ONE SHOULD BE CAUTIOUS WHEN USING IT IN REVISION SINUS SURGERY. REPORTED EVENT A 65 YEAR OLD MAN WHO EXPERIENCED CEREBROSPINAL FLUID LEAK DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993924 SYSTEM 9733560 FUSION EM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O