BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA SINUS BALLOON CATHETER SYSTEM

    MDR report key: 3761017 · Received April 11, 2014

    Report

    Report Number
    3005172759-2014-00009
    Event Type
    Injury
    Date Received
    April 11, 2014
    Report Date
    March 31, 2014
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VP OF MEDICAL AFFAIRS REVIEWED THE POST AND CONCLUDED THAT THERE WAS NOT ENOUGH INFORMATION TO KNOW IF THE ACCLARENT DEVICES WERE PART OF THE SURGERY. THE POST INDICATED THAT THE PT HAD BALLOON SINUPLASTY PROCEDURE BUT THERE ARE MANY SURGEONS USING ANY BALLOON FROM ANY MFR AND USE BALLOON SINUPLASTY THIS TERM. PER VP OF MEDIAL AFFAIRS COMMENT, IT IS HIGHLY CSF LEAK. MORE LIKELY IS THAT THE CASE WAS HYBRID CASE (BALLOON SINUPLASTY PROCEDURE PLUS TRADITIONAL TOOLS). ACCLARENT REGIONAL MGR CONFIRMED THAT THERE WERE NO CSF LEAK EVENTS THAT SHE WAS AWARE OF. THERE ARE NO EVIDENCES THAT THE ACCLARENT DEVICES CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNK. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ACCLARENT WAS MADE AWARE OF THIS EVENT ON 03-31-2014 WHEN A COMMENT WAS POSTED ON THE ACCLARENT (B)(4). THE COMMENT MENTIONED THAT THE PT HAD THE BALLOON SINUPLASTY PROCEDURE BY A PHYSICIAN IN (B)(6). FEW DAYS AFTER THE PROCEDURE, THE PT WAS ADMITTED TO (B)(6) WITH A CEREBROSPINAL FLUID LEAK CAUSED BY THE PHYSICIAN, WHO PERFORATED THE ETHMOID ROOF. THE HEAD AND NECK SURGEON MADE A PATCH FROM THE BEHIND THE PT'S EAR AND PATCH IS HEALING NICELY BUT NOW THE PT ALLEGED EXPERIENCING VISION PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220667 RELIEVA SINUS BALLOON CATHETER SYSTEM SINUS BALLOON CATHETER KAM ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention