BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA SPIN BALLOON SINUPLASTY SYSTEM

    MDR report key: 4184198 · Received October 16, 2014

    Report

    Report Number
    3005172759-2014-00029
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K111875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS DISCARDED BY THE USER FACILITY AND WAS NOT AVAILABLE FOR EVALUATION. REVIEW OF MANUFACTURING RECORDS ASSOCIATED WITH THE SUBJECT DEVICE DID NOT DETECT ANY ANOMALIES. THE PHYSICIAN REPORTED HAVING NO DIFFICULTIES IN USING THE ACCLARENT DEVICE DURING OR AFTER THE PROCEDURE. THE EXTENT TO WHICH THE SUBJECT DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFO IS RECEIVED REGARDING THIS REPORT, A SUPPLEMENTAL REPORT WILL BE FILED. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED OF AN EVENT THAT OCCURRED DURING A PROCEDURE IN WHICH A RELIEV A SPIN BALLOON SINUPLASTY SYSTEM AND TRADITIONAL RIGID INSTRUMENTS, INCLUDING AN UNIDENTIFIED FREER-ELEVATOR DEVICE WERE USED. THE PROCEDURE WAS SAID TO INVOLVE BILATERAL FRONTAL, MAXILLARY AND SPHENOID SINUS DILATION. A PREOPERATIVE CT SCAN HAD BEEN PERFORMED WHICH REPORTEDLY IDENTIFIED NO SKULL BASE DEFECT. FOLLOWING DILATION OF BOTH FRONTAL AND MAXILLARY SINUSES, AND ONE SPHENOID SINUS, THE PHYSICIAN BEGAN DILATING THE SECOND SPHENOID SINUS. DURING DILATION, THE PHYSICIAN REPORTED HAVING OBSERVED CLEAR FLUID LEAKING FROM THE PATIENT'S NOSE, AND IDENTIFIED A CSF LEAK FROM THE AREA OF THE CRIBRIFORM PLATE. THE PATIENT WAS TRANSFERRED TO A LOCAL HOSPITAL VIA AMBULANCE WHERE A SUBSEQUENT CT SCAN IDENTIFIED A SKULL BASE DEFECT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE THE ATTENDING SURGEON REPORTEDLY IDENTIFIED THE CEREBROSPINAL FLUID LEAK IN THE PATIENT'S SPHENOID SINUS, AND THE LEAK WAS REPAIRED UNDER GENERAL ANESTHESIA. SOMETIME THEREAFTER, THE PATIENT REPORTEDLY EXPERIENCED A "CEREBROVASCULAR ACCIDENT", WHICH THE SURGEON REPORTED MOST LIKELY RELATED TO SPASM OF REGIONAL BLOOD VESSELS. ACCLARENT FOLLOWED UP WITH THE USER FACILITY AND WAS INFORMED THA THE PATIENT WAS RELEASED FROM THE HOSPITAL AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656719 RELIEVA SPIN BALLOON SINUPLASTY SYSTEM SINUS BALLOON CATHETER LRC ACCLARENT, INC. NA 140606A-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention MODEL#: UNK, THERAPY DATE:| FREER-ELEVATOR AND OTHER RIGID INSTRUMENTATION,