BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 1PK

    MDR report key: 19707425 · Received July 9, 2024

    Report

    Report Number
    3005172759-2024-00074
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 9, 2024
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PNZ
    PMA / PMN Number
    DEN150056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.4: THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. SECTION E.1: THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. 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 INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, PRODUCT ANALYSIS CANNOT BE PERFORMED. IN ADDITION, THERE WAS NO REPORT OF DEVICE PERFORMANCE ISSUE / DEVICE MALFUNCTION DURING THE PROCEDURE. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, MANUFACTURING DOCUMENTATION REVIEW WAS NOT PERFORMED. SINCE MEDICAL OR SURGICAL INTERVENTION MAY BE REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE THIS ADVERSE EVENT MEETS US FDA REPORTING UNDER CRITERIA 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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. 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 EUSTACHIAN TUBE DILATION PROCEDURE USING AN ACCLARENT AERA EUSTACHIAN TUBE BALLOON (EU061655Z / LOT# UNKNOWN), IT APPEARED THE PHYSICIAN MAY HAVE ¿GONE SUBCUTANEOUS WITH THE BALLOON AND PIERCED THE TISSUE.¿ THE INITIAL REPORTER STATED THAT ¿IT LOOKED LIKE IT DIDN¿T ACTUALLY PENETRATE THE EUSTACHIAN TUBE ORIFICE. THEY DID GO IN AGAIN AND THEY WERE ABLE TO COMPLETE THE EUSTACHIAN TUBE DILATION.¿ IT WAS FURTHER REPORTED THAT ¿IT WASN¿T SUPER BLOODY AND THE PATIENT WASN¿T COMPLAINING OF PAIN DURING THE PROCEDURE.¿ THE PATIENT WAS REPORTED TO BE DOING FINE. THE PATIENT INFORMED THE PHYSICIAN THAT HE WAS DIZZY BUT HAD NO PAIN. ON 02-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE LOT NUMBER OF THE AERA EUSTACHIAN TUBE IS UNKNOWN. THERE WAS NO DEVICE MALFUNCTION DURING THE PROCEDURE. THE INFORMATION INDICATED THAT ¿IT WAS PERCEIVED THAT THE DOCTOR MAY HAVE CREATED A FALSE PASSAGE, SUBCUTANEOUSLY. IT WAS HARD TO TELL IF THE DOCTOR CREATED A FALSE PASSAGE. ULTIMATELY, HE WAS ABLE TO DILATE THE EUSTACHIAN TUBE BUT THERE WAS A MARK IN THE PTS TISSUE AFTER THE FIRST ATTEMPT TO INSERT THE BALLOON INTO THE EUSTACHIAN TUBE ORIFICE.¿ THE ENTC CANNOT RECALL WHETHER IT WAS THE RIGHT OR THE LEFT EUSTACHIAN TUBE THAT WAS BEING TREATED. THE INFORMATION INDICATED THAT IT WAS THE NEXT DAY (AFTER THE PROCEDURE) WHEN THE PATIENT EXPERIENCED DIZZINESS IN THE EARLY MORNING; BUT THE PATIENT WAS OTHERWISE FINE. THE PATIENT IS AN OLDER GENTLEMAN ¿ NOT UNDER 18 YEARS OF AGE AT THE TIME OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254887 ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 1PK EUSTACHIAN TUBE BALLOON DILATION DEVICE PNZ ACCLARENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other