BEUDAMED
    FDA Adverse Event Other Summary report: N

    LELIEVA SOLO PRO SINUS BALLOON CATHETER

    MDR report key: 2654321 · Received July 2, 2012

    Report

    Report Number
    3005172759-2012-00022
    Event Type
    Other
    Date Received
    July 2, 2012
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K061903
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT, AND SPOKE WITH THE PHYSICIAN THAT PERFORMED THE PROCEDURE ON (B)(4) 2011. THE PHYSICIAN STATED THAT THE SUBJECT DEVICE HAD WORKED AS EXPECTED AND A POSSIBLE REASON FOR THE GUIDEWIRE TRAVELING OUTSIDE OF THE SINUS WAS RELATED TO A DEHISCENCE FROM A SCAR, PREVIOUS SURGERY, THE PT'S EXISTING TUMOR, OR SOME COMBINATION OF THESE FACTORS. ACCLARENT WAS ALSO INFORMED THAT THE PT HAD BEEN SEEN ON MULTIPLE OCCURRENCES FOLLOWING THE PROCEDURE, AND THERE WERE NO SEQUELAE. NO PRODUCTS WERE RETURNED FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE DETERMINED, HOWEVER THE PT'S ANATOMY AND/OR UNDERLYING PHYSIOLOGY CANNOT BE RULED OUT AS CONTRIBUTORY FACTORS. THIS PHENOMENON WILL BE MONITORED FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE SUBJECT DEVICE WAS USED TO DILATE THE OUTFLOW OF THE LEFT FRONTAL SINUS IN A PT WITH A KNOWN PRE-EXITING HEMGIOPERICYTOMA IN THE LEFT NASAL CAVITY. THE USERS REPORTED THAT DURING THE PROCEDURE, THE LIGHT FROM THE LUMA SENTRY GUIDE WIRE HAD BEEN VISUALIZED NEAR THE TOP OF THE SKULL, AND THE PHYSICIAN BECAME CONCERNED THAT THE WIRE HAD TRAVERSED THE CRANIAL SPACE. THE WIRE WAS WITHDRAWN. FOLLOWING DILATION OF THE OSTIUM, VISUALIZATION OF THE LEFT FRONTAL SINUS WAS IMPROVED, AND A NON-PULSATILE CYSTIC MASS WAS OBSERVED IN THE NASAL CAVITY, WITH A VERY SMALL AREA OF POSSIBLE CEREBROSPINAL FLUID. TISSUE SEALANT AND GELFOAM WERE APPLIED IN THE AREA OF THE LEAK. THE PT WAS HELD OVERNIGHT FOR OBSERVATION, AND DISCHARGED THE FOLLOWING DAY. THE PT EXPERIENCED NO SEQUELAE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LELIEVA SOLO PRO SINUS BALLOON CATHETER SINUS BALLOON CATHETER LRC ACCLARENT, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention RELIEVA LUMA SINUS ILLUMINATION SYSTEM:| LOT # UNKNOWN