UNK_EUSTACHIAN TUBE
Report
- Report Number
- 3005172759-2024-00055
- Event Type
- Injury
- Date Received
- May 1, 2024
- Date of Event
- February 22, 2024
- Report Date
- May 13, 2024
- Manufacturer
- ACCLARENT, INC.
- Product Code
- PNZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE INDEPENDENT PHYSICIAN REVIEW OF THE MEDICAL NOTES, AUDIOGRAMS, AND ADDITIONAL INFORMATION THAT WERE RECEIVED FROM THE PHYSICIAN ON 01-MAY-2024. THE MEDICAL NOTES, AUDIOGRAMS, AND ADDITIONAL INFORMATION RECEIVED UNDERWENT INDEPENDENT PHYSICIAN REVIEW. THE ASSESSMENT IS DOCUMENTED BELOW. ¿WHEN LOOKING AT NOTES AUDIOGRAM AND CT SCAN IT SHOWS THE PRESENCE OF A HEARING LOSS IN THE PREOPERATIVE TIME PERIOD. ON THE RIGHT SIDE SHE WAS TOLD THAT A PERFORATION WAS PRESENT AND WAS GIVEN ANTIBIOTICS AND A STEROID. THE PERFORATION WAS NO LONGER PRESENT ON EXAM DEC (B)(6) AND FLUID WAS PRESENT. PATIENT HAD A PREVIOUS HISTORY OF HEARING LOSS WITH KNOWN USE OF HEARING AIDS. PATIENT UNDERWENT BL ETBD ON (B)(6). PATIENT WAS SEEN TWO MONTHS LATER WITH CHANGE IN HER HEARING AND CONTINUED SYMPTOMS. HEARING TEST PRE AND POST OP DEMONSTRATES MIXED HEARING LOSS WITH STABLE WORD RECOGNITION. MIXED LOSS AFTER ETBD PROGRESSED. R TYMPANOGRAM PRE-AND POST-SHOWS ABNORMALITY.¿ PHYSICIAN NAME AND DATE REVIEWED: (B)(6), (B)(6)2024. UPDATED SECTIONS: B.4, G.3, G.6, H.2, AND H.11. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3005172759-2024-00055 AND 3005172759-2024-00056. 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.
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION B.3: DATE OF EVENT: PROCEDURE DATE IS NOT KNOWN; IT WAS REPORTED TO BE IN (B)(6) 2024. SECTION D.4: THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. SECTION E.1: THE INITIAL REPORTER PHONE 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 WAS 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 LIMITED INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, PRODUCT ANALYSIS CANNOT BE CONDUCTED. IT WAS ALSO NOT KNOWN IF THERE WAS ANY DEVICE PERFORMANCE ISSUE / DEVICE MALFUNCTION DURING THE INDEX PROCEDURE. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, MANUFACTURING DOCUMENTATION REVIEW WAS NOT PERFORMED. SENSORINEURAL HEARING LOSS IS AN ADVERSE EVENT RESULTED, AN UNDESIRABLE MEDICAL EFFECT ASSOCIATED WITH THE USE OR MISUSE OF THE ACCLARENT DEVICES AND CAN RESULTED IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS CONSIDERED SERIOUS AND REPORTABLE. 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 IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3005172759-2024-00055 AND 3005172759-2024-00056. 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.
MANUFACTURER¿S REF. NO:(B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 01-MAY-2024. [ADDITIONAL INFORMATION]: ON 01-MAY-2024, ADDITIONAL INFORMATION AND MEDICAL NOTES WERE RECEIVED FROM THE PHYSICIAN. HISTORY AND PHYSICAL DOCUMENTED ON VISIT DATE 05-DEC-2023: THE CHIEF COMPLAINT FROM THE PATIENT IS HEARING LOSS. THE HISTORY OF PRESENT ILLNESS IS AS FOLLOWS: THE PATIENT IS A 79-YEAR-OLD FEMALE WHO PRESENTS WITH MODERATE LOSS OF HEARING INVOLVING THE RIGHT EAR. THE HEARING LOSS BEGAN SUDDENLY 1 MONTH AGO AND MAY BE RELATED TO TM PERFORATION. THERE IS NO HISTORY OF NOISE EXPOSURE AND EXPOSURE TO OTOTOXIC MEDICATIONS. THE PATIENT REPORTS ADDITIONAL COMPLAINTS, INCLUDING TINNITUS, FULLNESS IN THE RIGHT EAR, AND IMBALANCE. THE PATIENT DENIES OTALGIA AND OTORRHEA. THE HEARING LOSS IS AGGRAVATED BY NO KNOWN FACTORS. THERE ARE NO NOTED ALLEVIATING FACTORS. HER PAST MEDICAL HISTORY IS NOTABLE FOR HEARING LOSS, USES HEARING AIDS. THE PATIENT WAS TOLD SHE HAD TM PERFORATION. SHE HAS BEEN TREATED WITH MEDROL AND Z PACK. (B)(6) 2024: REPORT OF AUDIOLOGIC EVALUATION INDICATES THE FOLLOWING: R ¿ MILD TO SEVERE MIXED HEARING LOSS (MHL) WITH FAIR DISCRIMINATION. L ¿ MILD TO MODERATE/SEVERE SENSORINEURAL HEARING LOSS (SNHL) WITH FAIR DISCRIMINATION. (B)(6) 2024: NEUROSKELETAL IMAGING EXAM WAS PERFORMED WITH THE FOLLOWING FINDINGS: AXIAL COMPUTERIZED TOMOGRAPHY WAS DONE THROUGH THE TEMPORAL BONDS AND WAS FOLLOWED BY AXIAL AND CORONAL RECONSTRUCTED IMAGES. THERE IS DIFFUSE OPACIFICATION OF THE RIGHT MASTOID AIR CELLS WHICH CAN BE SEEN IN TRAPPED FLUID OR MASTOIDITIS. THERE IS NO DEFINITE EVIDENCE FOR AGGRESSIVE BONE DESTRUCTION . THERE IS ALSO MINIMAL OPACIFICATION OF THE LEFT MASTOID AIR CELLS WHICH IS NOT NEARLY AS PRONOUNCED. THE EXTERNAL AUDITORY CANALS, MIDDLE EAR CAVITIES, AND MIDDLE EAR OSSICLES ARE UNREMARKABLE. THE OVAL WINDOWS ARE INTACT. THE INTERNAL AUDITORY CANALS, COCHLEA, AND SEMICIRCULAR CANALS ARE UNREMARKABLE. THERE IS NO DEHISCENCE. THE VESTIBULES AND VESTIBULAR AQUEDUCTS ARE UNREMARKABLE. THE POSTERIOR WALL OF THE NASOPHARYNX IS UNREMARKABLE. THE CAROTID CANALS AND JUGULAR FORAMINA ARE UNREMARKABLE. IMPRESSION: THERE IS DIFFUSE OPACIFICATION OF THE RIGHT MASTOID AIR CELLS WHICH CAN BE SEEN IN TRAPPED FLUID OR MASTOIDITIS. PROCEDURE NOTE ON DATE OF PROCEDURE: (B)(6) 2024: PREOPERATIVE DIAGNOSIS: EUSTACHIAN TUBE DYSFUNCTION. POSTOPERATIVE DIAGNOSIS: SAME. PROCEDURE: BILATERAL EUSTACHIAN TUBE BALLOON DILATION. TOPICAL ANESTHETIC. AFTER INFORMED CONSENT, THE PATIENT WAS TOPICALLY ANESTHETIZED AND DECONGESTED WITH AFRIN AND TETRACAINE. 7% TETRACAINE AND LIDOCAINE EAR DROPS WERE INSTILLED. 4% TETRACAINE SOAKED COTTONOIDS WERE PLACED IN BOTH NASAL PASSAGES AND LEFT FOR SEVERAL MINUTES. NEXT, THE COTTONOIDS WERE REMOVED. 7% TETRACAINE / LIDOCAINE CREAM WAS INSTILLED INTO BOTH EUSTACHIAN TUBE ORIFICES UNDER ENDOSCOPIC VISUALIZATION. AFTER SEVERAL MINUTES, THE ACCLARENT EUSTACHIAN TUBE BALLOON DILATOR WAS INTRODUCED INTO THE LEFT EUSTACHIAN TUBE UNDER ENDOSCOPIC VISUALIZATION. THE BALLOON WAS ADVANCED, INFLATED TO 12 ATM AND LEFT INTO PLACE FOR 2 MINUTES. IT WAS WITHDRAWN AND REPEATED ON THE RIGHT SIDE. PATIENT TOLERATED WELL WITH MINIMAL PAIN. PROGRESS NOTE ON FOLLOW-UP VISIT: (B)(6) 2024: THE CHIEF COMPLAINT FROM THE PATIENT IS ETD F/U. THE HISTORY OF PRESENT ILLNESS IS AS FOLLOWS: THE PATIENT IS A 79-YEAR-OLD CAUCASIAN/WHITE FEMALE WHO PRESENTS FOR POSTOPERATIVE VISIT FOLLOWING BALLOON DILATION OF EUSTACHIAN TUBES ON (B)(6) 2024. SINCE SURGERY, SHE IS NOT DOING WELL, AND THE FOLLOWING IS REPORTED: RIGHT-SIDED HEARING LOSS. SYMPTOMS DENIED POSTOPERATIVELY INCLUDE PAIN AND OTORRHEA. THE PATIENT STATES THE SYMPTOMS HAVE NOT CHANGED SINCE THE SURGERY. AUDIOGRAM SHOWS BILATERAL PROFOUND HIGH FREQUENCY (HF) SNHL, CHANGE AT 6, 8K FROM AUDIOGRAM (B)(6) 2024. AS TYMP ON RIGHT, A ON LEFT. PROBLEM RECONCILED PLAN: ORDERS TYMPANOMETRY (IMPEDANCE TESTING) (92567, 92559) ¿ (B)(6) 2024 ¿ HOLD LAB RESULTS UNTIL REVIEWED: NO. COMPLETE AUDIO (92557) ¿ (B)(6) 2024 HOLD LAB RESULTS UNTIL REVIEWED: NO. ASSESSMENT: 3) EUSTACHIAN TUBE DYSFUNCTION 381.81/H69.90. 4) SNHL (SENSORINEURAL HEARING LOSS) 389.10/H90.5. MEDICATIONS PRESCRIBED ON (B)(6) 2024: PREDNISONE 20 MG TABLET. SIG: TAKE 60 TABLETS BY ORAL ROUTE DAILY FOR 7 DAYS. DISP: (18) TABLET WITH 0 REFILLS. INSTRUCTIONS: PATIENT NEEDS FOLLOW-UP AUDIOGRAM; DISCUSSED ONLY CITED DATA THAT .008% OF SNHL ASSOCIATED WITH BALLOON DILATION OF EUSTACHIAN TUBES IS PERMANENT. PATIENT IS LEAVING TOWN THIS WEEKEND. ELECTRONICALLY IDENTIFIED PATIENT EDUCATION MATERIALS PROVIDED ELECTRONICALLY. DISPOSITION: CALL OR RETURN IF SYMPTOMS WORSEN OR PERSIST. (B)(6) 2024: REPORT OF AUDIOLOGIC EVALUATION INDICATES THE FOLLOWING: L ¿ MILD TO PROFOUND MIXED LOSS WITH GOOD DISCRIMINATION. R ¿ MODERATE TO PROFOUND MIXED LOSS WITH FAIR DISCRIMINATION. THE ADDITIONAL INFORMATION INDICATED THAT THE CATALOG AND LOT NUMBERS OF THE DEVICES ARE NOT AVAILABLE. PER THE PHYSICIAN, IT WAS AN ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATOR AND AN ACCLARENT SEID. THERE WAS NO DEVICE PERFORMANCE ISSUE / MALFUNCTION AT THE TIME OF THE BALLOON DILATION. THE FIRST REPORT OF ANY HEARING LOSS WAS AT HER POST-OP VISIT ON (B)(6) 2024. PRIOR TO THE PROCEDURE, SHE HAS AN AS TYMPANOGRAM ON THE RIGHT SIDE, AN A TYMPANOGRAM ON THE LEFT WITH MODERATE BILATERAL SNHL. THE PHYSICIAN STATED THAT TO THE BEST OF HER KNOWLEDGE, THERE WAS NO NOISE EXPOSURE. THERE WAS NO EAR INFECTIONS AROUND THE TIME OF THE EUSTACHIAN TUBE PROCEDURE OR SINCE THE PROCEDURE. THE PATIENT PROGRESSED FROM MODERATE SNHL BILATERALLY IN (B)(6) 2024 TO A PROFOUND BILATERAL HIGH FREQUENCY SNHL ON (B)(6) 2024, AFTER THE PROCEDURE. THE PATIENT WAS STARTED ON HIGH DOSE PREDNISONE AT HER POST-OP VISIT. ¿SHE UNFORTUNATELY IS A WINTER RESIDENT IN FLORIDA AND HAS RETURNED TO HER HOME UP NORTH FOR FURTHER FOLLOW-UP.¿ THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3005172759-2024-00055 AND 3005172759-2024-00056. 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.
THE ENT CONSULTANT REPORTED THAT ON (B)(6) 2024, THE PHYSICIAN REPORTED SENSORINEURAL HEARING LOSS IN A PATIENT. THE PATIENT HAD A 6-8 WEEK FOLLOW-UP VISIT IN WHICH THE PATIENT UNDERWENT AN AUDIO EXAM WITH THE PHYSICIAN AFTER UNDERGOING A EUSTACHIAN TUBE PROCEDURE IN (B)(6) 2024; THE EXACT DATE WAS NOT KNOWN/REPORTED. THE ENT CONSULTANT DID NOT HAVE ANY PRODUCT INFORMATION AVAILABLE FOR THE ACCLARENT EUSTACHIAN TUBE BALLOON (CATALOG / LOT# UNKNOWN) AND THE ACCLARENT SE INFLATION DEVICE (SEID) (CATALOG / LOT# UNKNOWN). MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE DEVICES USED WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148098 | UNK_EUSTACHIAN TUBE | EUSTACHIAN TUBE BALLOON DILATION DEVICE | PNZ | ACCLARENT, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Disability | UNK_INFLATION DEVICE (1ST GEN) |