BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA SPIN SINUPLASTY SYSTEM

    MDR report key: 6168064 · Received December 12, 2016

    Report

    Report Number
    3005172759-2016-00021
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    September 2, 2015
    Report Date
    September 2, 2015
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K111875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AGE OF THE PATIENT IS NOT KNOWN. THE USER FACILITY RETURNED ONE (1) RELIEVA SPIN BALLOON SINUPLASTY SYSTEM WITH A RELIEVA LUMA SENTRY¿ SINUS ILLUMINATION SYSTEM, AND AN F-70 SINUS GUIDE CATHETER TIP. THE FOLLOWING OBSERVATIONS WERE NOTED: THE BALLOON CATHETER WAS WRINKLED, AND THE TIP WAS COLLAPSED AND DETACHED FROM THE SHAFT. UPON FURTHER INSPECTION UNDER THE MICROSCOPE, IT WAS OBSERVED THAT THE INNER SHAFT OF THE SINUS BALLOON BROKE OFF NEAR THE MIDDLE AND A TEAR WAS NOTED ON THE PROXIMAL OF THE BALLOON. THE SHAFT WAS ALSO INSPECTED UNDER THE MICROSCOPE AND THE BROKEN OFF EDGE APPEARED JAGGED WHICH WAS LIKELY CAUSED BY EXCESSIVE FORCE DURING USE. DUE TO THE CONDITION OF THE RETURNED DEVICE, TESTING OF THE BALLOON WAS NOT ABLE TO BE REPLICATED IN THE TESTING ENVIRONMENT. BASED ON ANALYSIS FINDINGS, THE REPORTED COMPLAINT WAS CONFIRMED. PRODUCT ANALYSIS WAS ALSO CONDUCTED ON THE RETURNED GUIDE WIRE AND GUIDE CATHETER; HOWEVER THE OBSERVATIONS AND RESULTS OF THESE ARE UNRELATED TO THE ALLEGED COMPLAINT. VISUAL INSPECTION OF THE GUIDE WIRE FOUND NO ANOMALIES. THE GUIDE WIRE WAS CONNECTED TO THE XENON LIGHT SOURCE TO VERIFY THE LIGHT OUTPUT. THE LIGHT OUTPUT WAS TRANSMITTED AND THE MEASUREMENT WAS WITHIN SPECIFICATIONS. THE RETURNED GUIDE CATHETER WAS CHECKED UNDER THE MICROSCOPE AND DELAMINATION ON THE BLUE TIP WAS OBSERVED. A REVIEW OF THE LOT HISTORY RECORD FOR THE SUBJECT DEVICE DID NOT NOTE ANY ANOMALIES.

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED THAT DURING A PRIMARY BALLOON SINUPLASTY PROCEDURE, THE BALLOON CATHETER POPPED, DETACHED AND GOT STUCK IN THE RIGHT MAXILLARY SINUS. THE BALLOON CATHETER WAS REPLACED AND THE BALLOON POPPED AGAIN. ADDITIONAL INFORMATION WAS OBTAINED AND FOUND THAT THE BALLOON WAS COMPLETELY DETACHED AND FELL INTO THE MAXILLARY SINUS. THE BALLOON WAS COMPLETELY RETRIEVED USING THE TAKAHASHI FORCEPS, NO FURTHER SURGERY WAS PERFORMED. THE PATIENT WAS REPORTED AS DOING WELL FOLLOWING THE PROCEDURE; THERE WERE NO COMPLICATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818359 RELIEVA SPIN SINUPLASTY SYSTEM INSTRUMENT, ENT MANUAL SURGICAL LRC ACCLARENT, INC. NA 140401B-CM

    Patients

    Seq Age Sex Outcome Treatment
    1