BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA SPIN BALLOON SINUPLASTY SYSTEM

    MDR report key: 3964848 · Received July 16, 2014

    Report

    Report Number
    3005172759-2014-00016
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K111875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS DISCARDED AND WAS NOT AVAILABLE FOR EVALUATION. THE USER DID NOT REPORT ANY DIFFICULTY ASSOCIATED WITH THE OPERATION OF DEVICE DURING OR AFTER THE PROCEDURE. THE CAUSE OF THE REPORTED DIFFICULTY COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED, AND ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED THAT SWELLING WAS OBSERVED AROUND A PATIENT'S RIGHT EYE FOLLOWING BILATERAL MAXILLARY SINUS DILATION WITH LAVAGE IN A PROCEDURE IN WHICH AN ACCLARENT SPIN BALLOON SINUPLASTY SYSTEM AND VORTEX 2 IRRIGATION CATHETER WERE USED. THE PHYSICIAN WAS CONCERNED THAT THE SALINE USED DURING THE LAVAGE HAD INFILTRATED THE ORBITAL SPACE AND WAS THE CAUSE OF THE SWELLING, AND PERFORMED AN UNCINECTOMY TO INSPECT THE RIGHT MAXILLARY SINUS. BY APPLYING PRESSURE TO THE SWOLLEN AREA EXTERNALLY, THE PHYSICIAN WAS ABLE TO IDENTIFY A DEHISCENCE AREA NEAR THE RIGHT ORBITAL WHERE SALINE WAS ESCAPING. THE PHYSICIAN CONTINUED TO APPLY EXTERNAL PRESSURE WHILE SUCTIONING NEAR THE DEHISCENCE SITE. THE SWELLING REPORTEDLY SUBSIDED AND THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS SAID TO BE "FINE' AND DID NOT HAVE FURTHER SEQUELAE FROM THE OPERATION. THE PHYSICIAN REPORTED THAT IT IS UNCLEAR IF THE DEHISCENCE WAS CREATED DURING THE PROCEDURE OR IF IT EXISTED PRIOR TO THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416076 RELIEVA SPIN BALLOON SINUPLASTY SYSTEM SINUS BALLOON CATHETER LRC ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ACCLARENT RELIEVA VORTEX 2 IRRIGATION CATHETER