BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK

    MDR report key: 8516699 · Received April 15, 2019

    Report

    Report Number
    3005172759-2019-00120
    Event Type
    Injury
    Date Received
    April 15, 2019
    Date of Event
    March 15, 2019
    Report Date
    March 16, 2019
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PNZ
    UDI-DI
    10705031230880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO.: (B)(4). 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 · 1

    MANUFACTURER¿S REF. NO.: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. LOT #, EXPIRATION DATE: THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT A FEMALE PATIENT UNDERWENT BILATERAL EUSTACHIAN TUBE (ET) DILATION WITH THE ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM (EU061655 / LOT# UNKNOWN) ON (B)(6) 2019. THE UNEVENTFUL PROCEDURE WAS COMPLETED WITHOUT ANY RESISTANCE OR BLEEDING. A SINGLE DILATION WAS COMPLETED BILATERALLY AT 12 ATM FOR 2 MINUTES. THERE WAS NO REPORT OF ANY ACCLARENT PRODUCT MALFUNCTION. THE PATIENT WAS DISCHARGED UNEVENTFULLY AS OUT-PATIENT AND WAS NOT GIVEN VALSALVA INSTRUCTION. POST-OPERATIVE DAY ONE, THE PATIENT REPORTED FEELING LIKE SHE WAS GETTING A COLD AND HAD SOME COUGHING. THE PATIENT CALLED FIRST POST-OPERATIVE DAY AND REPORTED RIGHT FACIAL SWELLING. THIS PROGRESSED TO INCLUDE MILD PAIN WITH SWALLOWING AND MILD DYSPHAGIA. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AND HAD A COMPUTED TOMOGRAPHY (CT) SCAN OF THE FACE/NECK/CHEST. THERE WAS AIR PRESENT ON THE RIGHT SIDE OF THE FACE, LIMITED AIR IN THE RIGHT UPPER-NECK REGION AND A TRACE AMOUNT OF AIR IN THE CHEST, ALL CONSISTENT WITH SUBCUTANEOUS EMPHYSEMA. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND GIVEN SUPPORTIVE ARE AND PARENTAL ANTIBIOTICS; THE PATIENT EXPERIENCED NO DISTRESS OTHER THAN THE FACIAL SWELLING. THE PATIENT WAS PERMITTED TO EAT WITHIN 24 HOURS. THE TREATING PHYSICIAN DECIDED TO PLACE THE CHEST TUBE IN ORDER TO HELP RESOLVE THE SUBCUTANEOUS EMPHYSEMA, THE PATIENT REMAINS WITHOUT ANY DISTRESS AND IS COMFORTABLE. IT WAS REPORTED THAT THE PATIENT IS DOING FINE, AND THE SYMPTOMS SUBSIDED A WEEK LATER. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BILATERAL ET DILATION WITH ACCLARENT AERA ET BALLOON FOR ETD SYMPTOMS COMPLETED PROCEDURE UNEVENTFULLY WITH NO RESISTANCE OR BLEEDING. A SINGLE DILATION WAS COMPLETED BILATERALLY AT 12 ATM FOR 2 MIN. THE PATIENT WAS DISMISSED UNEVENTFULLY AS OUT-PATIENT AND WAS NOT INSTRUCTED TO VALSALVA. THE PATIENT FELT LIKE SHE WAS GETTING A COLD POST-OPERATIVE DAY ONE AND HAD SOME COUGHING. SHE CALLED FIRST POSTOPERATIVE DAY REPORTING RIGHT FACIAL SWELLING. THIS PROGRESSED TO INCLUDE MILD PAIN WITH SWALLOWING AND MILD DYSPHAGIA. THE PATIENT WAS SENT TO THE ER AND HAD CT OF FACE/NECK/CHEST. THERE WAS AIR PRESENT ON THE RIGHT SIDE OF THE FACE, LIMITED AIR IN THE RIGHT UPPER NECK REGION AND TRACE AMOUNT OF AIR IN THE CHEST, ALL CONSISTENT WITH SUBCUTANEOUS EMPHYSEMA. THE PATIENT WAS ADMITTED TO THE ICU AND GIVEN SUPPORTIVE CARE AND PARENTERAL ANTIBIOTICS AND EXPERIENCED NO DISTRESS OTHER THAN THE FACIAL SWELLING. THE PATIENT WAS PERMITTED TO EAT WITHIN 24 HRS. THE TREATING PHYSICIAN DECIDED TO PLACE THE CHEST TUBE IN ORDER TO HELP SUBCUTANEOUS EMPHYSEMA RESOLVE¿, HOWEVER THE PATIENT WAS IN NO DISTRESS AND COMFORTABLE, AND THE AIR WAS NOT PROGRESSING. BECAUSE THE PATIENT WAS ASYMPTOMATIC AND DID NOT EXPERIENCE ANY RESPIRATORY COMPROMISE, THE SURGICAL INTERVENTION WAS NOT REQUIRED. THE ENT WAS NOT INVOLVED IN THIS DECISION. THE PATIENT HAS BEEN DISMISSED AS THE PROBLEM APPEARS TO BE RESOLVING WITHOUT INFECTION. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS CONSIDERED SERIOUS AND REPORTABLE. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. 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. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. THERE WAS NO REPORT OF ANY PRODUCT MALFUNCTION DURING THE PROCEDURE. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN, THEREFORE REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED. 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 · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT A FEMALE PATIENT UNDERWENT BILATERAL EUSTACHIAN TUBE (ET) DILATION WITH THE ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM (EU061655 / LOT# UNKNOWN) ON (B)(6) 2019. THE UNEVENTFUL PROCEDURE WAS COMPLETED WITHOUT ANY RESISTANCE OR BLEEDING. A SINGLE DILATION WAS COMPLETED BILATERALLY AT 12 ATM FOR 2 MINUTES. THERE WAS NO REPORT OF ANY ACCLARENT PRODUCT MALFUNCTION. THE PATIENT WAS DISCHARGED UNEVENTFULLY AS OUT-PATIENT AND WAS NOT GIVEN VALSALVA INSTRUCTION. POST-OPERATIVE DAY ONE, THE PATIENT REPORTED FEELING LIKE SHE WAS GETTING A COLD AND HAD SOME COUGHING. THE PATIENT CALLED FIRST POST-OPERATIVE DAY AND REPORTED RIGHT FACIAL SWELLING. THIS PROGRESSED TO INCLUDE MILD PAIN WITH SWALLOWING AND MILD DYSPHAGIA. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AND HAD A COMPUTED TOMOGRAPHY (CT) SCAN OF THE FACE/NECK/CHEST. THERE WAS AIR PRESENT ON THE RIGHT SIDE OF THE FACE, LIMITED AIR IN THE RIGHT UPPER-NECK REGION AND A TRACE AMOUNT OF AIR IN THE CHEST, ALL CONSISTENT WITH SUBCUTANEOUS EMPHYSEMA. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND GIVEN SUPPORTIVE ARE AND PARENTAL ANTIBIOTICS; THE PATIENT EXPERIENCED NO DISTRESS OTHER THAN THE FACIAL SWELLING. THE PATIENT WAS PERMITTED TO EAT WITHIN 24 HOURS. THE TREATING PHYSICIAN DECIDED TO PLACE THE CHEST TUBE IN ORDER TO HELP RESOLVE THE SUBCUTANEOUS EMPHYSEMA, THE PATIENT REMAINS WITHOUT ANY DISTRESS AND IS COMFORTABLE. IT WAS REPORTED THAT THE PATIENT IS DOING FINE, AND THE SYMPTOMS SUBSIDED A WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309738 ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK EUSTACHIAN TUBE BALLOON DILATION DEVICE PNZ ACCLARENT, INC. 10705031230880

    Patients

    Seq Age Sex Outcome Treatment
    1 Other