BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM

    MDR report key: 20138080 · Received September 4, 2024

    Report

    Report Number
    3005172759-2024-00086
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ACCLARENT, INC.
    Product Code
    QGK
    UDI-DI
    10705031462649
    PMA / PMN Number
    K183090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (230911B-PC) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND / OR DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ACCLARENT, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ACCLARENT, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE TOTAL SINUS BALLOON DILATION PROCEDURE ON (B)(6) 2024, A 6MM X 16MM RELIEVA SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM (RSP0616MFSN / 240422B-PC) STOPPED NAVIGATING ON THE TRUDI NAVIGATION SYSTEM HALFWAY THROUGH THE PROCEDURE. THE TRUDI NAVIGATION SYSTEM DISPLAYED AN ERROR THAT INDICATED THE DEVICE NEEDED TO BE CHANGED. THE CABLE WAS RESEATED MULTIPLE TIMES WITHOUT RESOLUTION AND THE SPINPLUS NAVIGATION BALLOON WAS REPLACED AND THE ISSUE WAS RESOLVED. DURING THE SAME PROCEDURE, IT WAS REPORTED THAT A 16MM X 40MM RELIEVA TRACT BALLOON (RT1640A / 230911B-PC) POPPED ON THE FIRST INFLATION. IT WAS REPORTED THAT THE BALLOON CATHETER PORTION BECAME UNATTACHED FROM THE PROXIMAL EDGE OF THE CATHETER. THE RELIEVA TRACT BALLOON CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700667 RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM BALLOON, NASAL AIRWAY QGK ACCLARENT, INC. 230911B-PC 10705031462649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown