BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1622969 · Received March 3, 2010

    Report

    Report Number
    3005172759-2010-00002
    Event Type
    Injury
    Date Received
    March 3, 2010
    Report Date
    March 1, 2010
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNCLEAR WHICH ACCLARENT INSTRUMENTS WERE USED FOR THE PROCEDURE, IF ANY, THAT MAY HAVE CONTRIBUTED TO THE CSF LEAK. AN ATTEMPT FROM ACCLARENT'S MEDICAL DIRECTOR WAS MADE TO CONTACT THE AUTHOR OF THE ABSTRACT, WITH THE INTENT OF GATHERING RELEVANT DETAILS SUCH AS THE NAME OF THE PHYSICIAN, THE FACILITY LOCATION, THE OCCURRENCE DATE, TYPE OF DEVICE(S), PT FOLLOW-UP, ANY PRE-EXISTING PT CONDITIONS, ETC... AS OF 03/01/2010, THE ATTEMPT TO CONTACT THE PHYSICIAN HAS BEEN UNSUCCESSFUL. THE ABSTRACT DOES NOT MENTION WHETHER THE PT HAS ANY PREDISPOSING ANATOMICAL DEFECT, INJURY HISTORY, OR OTHER FACTORS THAT MAY HAVE CONTRIBUTED TO THE INJURY. THE ABSTRACT ALSO DOES NOT MENTION WHETHER BALLOON CATHETER DEVICES WERE THE ONLY SURGICAL INSTRUMENTS USED DURING THE CASE, OR WHETHER THE OPERATING SURGEON MAY HAVE ALSO USED TRADITIONAL RIGID STAINLESS STEEL CUTTING INSTRUMENTS AS WELL. A REVIEW OF THE HISTORICAL TRENDING WAS PERFORMED. NO TRENDS WERE NOTED DURING THE ANALYSIS OF OUR HISTORICAL DATA. TO DATE, THERE HAVE BEEN NO REPORTED COMPLAINTS OF BALLOON CATHETERS CAUSING A CSF LEAK. ACCLARENT'S FLEXIBLE BALLOON CATHETERS ARE SPECIFICALLY DESIGNED TO BE ATRAUMATIC, AND NOT DAMAGE TISSUE. THE LOT INFO WAS NOT AVAILABLE. IN ADDITION, NO DEVICE(S) WERE AVAILABLE FOR RETURN. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFO 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 02/01/2010 FROM AN ARTICLE ABSTRACT DISCOVERED BY AN ACCLARENT EMPLOYEE. A (B) (6) FEMALE PT WAS PRESENTED WITH RIGHT SIDED RHINORRHEA FROM A CSF-LEAK IN THE ETHMOIDAL ROOF AFTER BALLOON SINUPLASTY. THE ARTICLE NOTED THAT THE SURGEON WAS UNAWARE OF HAVING PENETRATED THE SKULL BASE THROUGH THE LATERAL LAMELLA OF THE CRIBRIFORM PLATE INTRAOPERATIVELY. CSF RHINORRHEA BECAME EVIDENT 3 WEEKS POSTOPERATIVELY ONLY WHEN FEVER, HEADACHES AND MODERATE NAUSEA DEVELOPED. THE ARTICLE DID NOT SPECIFY WHETHER THE OPERATING SURGEON USED THE BALLOON CATHETER WITH THE STANDARD ACCLARENT GUIDE AND GUIDEWIRE, AND IT IS ALSO UNK WHAT OTHER SURGICAL INSTRUMENTS WERE USED DURING THE PROCEDURE, HOWEVER, IT SUGGESTED THAT THE CSF LEAK WAS POTENTIALLY CAUSED BY A BALLOON CATHETER. THE PT WAS TREATED AND ACCORDING TO THE ARTICLE, HAS REMAINED FREE OF SYMPTOMS WITHOUT ANY EVIDENCE OF CSF LEAKAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other