BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK

    MDR report key: 16873218 · Received May 4, 2023

    Report

    Report Number
    3005172759-2023-00028
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    April 27, 2023
    Report Date
    July 13, 2023
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PNZ
    UDI-DI
    10705031230880
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE COMPONENT ON 29-MAY-2023. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, H.6, AND H.10. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION H.3: THE FOREIGN BODY / DEVICE COMPONENT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. SINCE THIS ADVERSE EVENT REQUIRED ADDITIONAL SURGICAL INTERVENTION/PROCEDURE TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS CONSIDERED SERIOUS AND REPORTABLE. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. THE REPORTED FOREIGN BODY WAS RETURNED AND RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE BLUE TIP WAS RETURNED CONTAINED IN A CLEAR CONTAINER INSIDE THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. IT WAS SUSPECTED TO BE PART OF THE BULB TIP OF THE AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM. FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY WAS PERFORMED ON THE MATERIAL OF THE RETURNED FOREIGN BODY AND ON A SAMPLE GUIDE CATHETER TIP AS THE CONTROL SAMPLE. THE RESULT OF THE FTIR ON THE FOREIGN MATERIAL SHOWED COMPOSITION FROM FUNCTIONAL GROUPS ASSOCIATED TO A CARBONATE-DERIVED MATERIAL. THE RESULT OF THE GUIDE CATHETER CONTROL SAMPLES SHOWED MAINLY CHARACTERISTIC PEBAX MOLECULAR VIBRATIONS. COMPARISON TEST SHOWED THAT BOTH SAMPLES SHARED PRINCIPAL ABSORPTION BANDS AGAINST THEIR REFERENCE SPECTRUMS. THE MAIN DIFFERENCES WERE OBSERVED IN THE UNKNOWN FOREIGN PARTICLE AGAINST CALCIUM CARBONATE REFERENCE SPECTRUM. AN INDICATION THAT THE SAMPLE IS MAINLY CONFORMED TO ANOTHER CARBONATE DERIVED MATERIAL, WHEREAS THE MATERIAL FROM THE CONTROL SAMPLE CONFORMED WITH THE CHEMICAL COMPOSITION OF THE AERA BALLOON CATHETER BULB TIP. IN CONCLUSION, THE RESULTS OBTAINED SHOWED DIFFERENT FTIR SPECTRUMS FOR THE SAMPLES. THE UNKNOWN FOREIGN SAMPLE IS FROM A CARBONATE DERIVED MATERIAL SPECTRUM AND THE CONTROL SAMPLE IS FROM A POLYETHER BLOCK AMIDE (PEBAX) MATERIAL SPECTRUM. THE CONTROL SAMPLE HAS CONFORMATION IN ACCORDANCE WITH ACCLARENT MATERIAL SPECIFICATION. HOWEVER, THERE IS NO SOURCE OF CARBONATE MATERIAL SPECIFIED TO INDICATE THE ORIGIN OF THE UNKNOWN BLUE FOREIGN PARTICLE. FROM VISUAL INSPECTION AND FTIR COMPARISON, IT IS CONFIRMED THAT THE UNKNOWN BLUE PARTICLE IS CONFORMED OF A DIFFERENT MATERIAL. THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT REGARDING THE SEPARATION OF THE BLUE BULB TIP OF THE AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM WAS NOT CONFIRMED BASED ON THE RESULTS OF FURTHER ANALYSIS OF THE MATERIAL COMPOSITION VIA FTIR SPECTROSCOPY. THE RESULTS INDICATED THAT THE MATERIAL COMPOSITION OF THE RETURNED FOREIGN MATERIAL DID NOT BELONG TO AN ACCLARENT DEVICE. HOWEVER, WITH THE LIMITED INFORMATION AVAILABLE AND RESULT FROM THE PARTICLE INSPECTION, THERE IS NO CLEAR INSIGHT / DETERMINATION INTO THE ROOT CAUSE AND/OR EXACT CONTRIBUTING FACTORS THAT MAY HAVE RESULTED IN THE FOREIGN MATERIAL BEING LODGED IN THE PATIENT¿S EAR CANAL. THERE IS NO INDICATION THAT THE REPORTED ISSUE IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE ACCLARENT DEVICE. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. AS PART OF ACCLARENT QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES FROM LEAVING THE FACILITY. 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. 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 THAT THE PATIENT UNDERWENT A PRIMARY EUSTACHIAN TUBE DILATION ON (B)(6) 2023 USING AN ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM (EU061655 / LOT# UNKNOWN). AT THE TIME OF THE PROCEDURE, THERE WERE NO PATIENT CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2023, THE PATIENT RETURNED TO THE CLINIC REPORTING OF LEFT EAR DISCOMFORT AND ITCHINESS. IT WAS CONFIRMED THAT A BLUE FOREIGN BODY WAS LODGED IN THE PATIENT¿S EAR CANAL. PER THE ACCLARENT ENT CONSULTANT, ¿THE TIP OF THE BALLOON DISLODGED AND EXTRUDED RETROGRADE INTO THE MIDDLE EAR AND OUT THROUGH THE MEMBRANE.¿ THE PHYSICIAN REMOVED THE FOREIGN BODY FROM THE EAR AND THERE WERE NO FURTHER MEDICAL INTERVENTION PERFORMED. IT WAS FURTHER REPORTED THAT THERE WERE NO FURTHER ISSUES WITH THE MIDDLE EAR OR THE EAR DRUM. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE AFFECTED EAR WAS THE LEFT EAR. PER THE ACCLARENT ENT CONSULTANT, THE FOREIGN BODY WAS REMOVED LIKELY WITH SOME FORCEPS. THE AERA BALLOON THAT WAS USED DURING THE PROCEDURE IS NOT AVAILABLE; IT WAS DISCARDED ON THE DAY OF THE INDEX PROCEDURE, (B)(6) 2023. THE ACCLARENT ENT CONSULTANT REPORTED THAT HE WAS NOT PRESENT ON THE DATE OF THE INDEX PROCEDURE. THE INFORMATION HE RECEIVED WAS THAT THE PATIENT HAD LEFT EAR DISCOMFORT AND ITCHINESS. THERE WAS NO ADVERSE EFFECTS; THE PATIENT IS STABLE. THE PATIENT DROVE TO THE PHYSICIAN¿S OFFICE ON (B)(6) 2023, TO DELIVER THE FOREIGN BODY THAT WAS REMOVED FROM HIS EAR, AND THE ENT CONSULTANT WAITED IN THE WAITING AREA ¿TO RETRIEVE IT FROM THE PHYSICIAN.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907195 ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK EUSTACHIAN TUBE BALLOON DILATION DEVICE PNZ ACCLARENT, INC. EU061655 10705031230880

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention