BEUDAMED
    FDA Adverse Event Summary report: N

    RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER

    MDR report key: 3736452 · Received April 3, 2014

    Report

    Report Number
    3005172759-2014-00008
    Date Received
    April 3, 2014
    Report Date
    March 5, 2014
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VP OF MEDICAL AFFAIRS TRIED TO CONTACT THE TREATING PHYSICIAN BY PHONE THREE TIMES BUT DID NOT RECEIVE ANY RESPONSE. BASED ON THE INFORMATION PROVIDED, THERE WAS NOT ENOUGH INFORMATION TO DETERMINE IF ACCLARENT DEVICES CAUSE OR CONTRIBUTE TO THE EVENT. THERE WAS NO INFORMATION PROVIDED IF OTHER MEDICAL INTERVENTION (E.G. INTRAVENOUS STEROID) WAS PERFORMED. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNKNOWN. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ACCLARENT WAS NOTIFIED ON (B)(6) 2014, OF A DOMESTIC EVENT THAT OCCURRED DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE PATIENT HAD EXPERIENCED RIGHT EYE SWELLING DURING A BALLOON SINUPLASTY PROCEDURE. THIS WAS THE FIRST SINUS TREATED. THE DOCTOR DID NOT GET LIGHT CONFIRMATION AND WAS HAVING DIFFICULTY ADVANCING THE BALLOON AND VORTEX CATHETER. THE SALINE INJECTED INTO THE ORBIT DURING IRRIGATION. NO OTHER PROCEDURES WERE CONDUCTED AT THAT TIME AND THERE WAS NO SURGERY REQUIRED TO REDUCE SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203347 RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER IRRIGATION CATHETER KAM ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCLARENT SPIN BALLOON CATHETER SYSTEM| A DOUBLE BALL PROBE (NON-ACCLARENT DEVICE)