BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA SOLO PRO SINUS BALLOON CATHETER

    MDR report key: 2654322 · Received July 2, 2012

    Report

    Report Number
    3005172759-2012-00021
    Event Type
    Other
    Date Received
    July 2, 2012
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K061903
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFO. THE PT HAD REPORTEDLY BEEN SEEN ON SEVERAL OCCASIONS FOLLOWING THE SURGERY, AND WAS SAID TO BE DOING WELL. THE PHYSICIAN THAT HAD USED THE DEVICE STATED THAT HE BELIEVED THAT IF THERE WAS A LEAK, IT ORIGINATED IN A DEHISCENCE IN LEFT MIDDLE TURBINATE AS IT MAY HAVE FRACTURED AT THE SUPERIOR ATTACHMENT WHEN IT WAS MEDIALIZED. THE PHYSICIAN INDICATED CANNULATION NEVER OCCURRED, THE BALLOON WAS NOT USED. NO PRODUCTS WERE RETURNED FOR EVALUATION. THE CAUSE OF THE ALLEGED LEAK COULD NOT BE DETERMINED. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A BALLOON SINUPLASTY PROCEDURE, THE USER ATTEMPTED TO ACCESS THE LEFT FRONTAL AND MAXILLARY SINUSES WITHOUT SUCCESS. THE PHYSICIAN ELECTED TO ACCESS THE SINUS SURGICALLY. ONE OF THE LEFT TURBINATES WAS REPORTED TO HAVE REQUIRED MEDIALIZATION DURING THE PROCEDURE. WHEN THE ENDOSCOPE WAS REINSERTED INTO THE PT, A SMALL AMOUNT OF WHAT SUSPECTED TO BE CEREBROSPINAL FLUID WAS OBSERVED IN THE SUPERIOR ASPECT OF THE MIDDLE MEATUS, HOWEVER, NO TRAUMA WAS DETECTED TO THE SINUS, AND THE SOURCE OF THE LEAKAGE COULD NOT BE DETERMINED. ANOTHER PHYSICIAN WAS SUMMONED, AND IT WAS DETERMINED THAT THE AMOUNT OF FLUID WAS SO SMALL THAT NO PATCH PROCEDURE WAS REQUIRED. PLEDGES WERE PLACED IN THE AREA OF THE FLUID, AND THE MAXILLARY SINUS WAS ACCESSED BY REMOVAL OF THE UNCINATE. NO HOSPITALIZATION WAS REQUIRED, AND THE PT WAS SAID TO HAVE DONE WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA SOLO PRO SINUS BALLOON CATHETER SINUS BALLOON CATHETER LRC ACCLARENT, INC. BC0716SP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SINUS GUIDE CATHETER TIP, FRONTAL, RSF70:| RELIEVA LUMA SINUS ILLUMINATION SYSTEM: LOT # UNK| MODEL 750, LOT # UNK