MAUDE Adverse Event Report: ACCLARENT, INC. ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK; UNKNOWN

Catalog Number EU061655

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); No Code Available (3191)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information regarding patient age, weight, race, ethnicity, and medical history were not provided.(b)(4).[conclusion]: the healthcare professional reported that on (b)(6) 2018, a female patient underwent a bilateral eustachian tube dilation using the acclarent aera eustachian tube balloon dilation system (eu061655 / lot number not available) and another hybrid procedure with non-acclarent devices to remove a cyst from the right side of the neck; the patient developed subcutaneous emphysema after she was discharged.The patient reported that she was getting ¿air in the neck¿ and was not able to pop her ear on one side.The patient was seen in the emergency room and had a computed tomography (ct) that revealed air in the right side of the face, limited air in the right upper neck, and trace of air in the right chest.The patient was admitted to the hospital for one night on high-flow oxygen to facilitate quick air absorption.The physician reported that the patient did not have any infection but received prophylactic intravenous (iv) antibiotics while she was in the hospital.The patient was transition augmentin as an outpatient.The physician reported that the patient recovered well with all symptoms resolved.There was no permanent injury suffered.The hybrid procedure performed was done prior to the eustachian tube dilation procedure.The physician reported that the patient underwent an excision of a left lower neck lymphangioma.A drain was placed in the neck and the wound was closed.The eustachian tube dilation procedure was performed uneventfully without resistance or bleeding.A single dilation at 12 atm was performed bilaterally for two minutes.Tympanostomy tubes were placed.There were no known procedural complications associated with the use of the aera eustachian tube balloon; the balloon operated without any malfunction.The balloon was discarded and is thus not available for return.Based on the information contained in the complaint at the time the reporting determination was made, this complaint is deemed reportable.Although the physician reported there was no permanent injury and the subcutaneous emphysema resolved, the patient received medical treatment and iv antibiotics prophylactically for her symptoms; therefore, this event is mdr reportable.Based on complaint information, the device was not available to be returned for analysis.The sterile lot number was not available for a lot history record review.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of causes and possible contributing factors could be made.As such the investigation will be closed.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.

Event Description

The healthcare professional reported that on (b)(6) 2018, a female patient underwent a bilateral eustachian tube dilation using the acclarent aera eustachian tube balloon dilation system (eu061655 / lot number not available) and another hybrid procedure with non-acclarent devices to remove a cyst from the right side of the neck; the patient developed subcutaneous emphysema after she was discharged.The patient reported that she was getting ¿air in the neck¿ and was not able to pop her ear on one side.The patient was seen in the emergency room and had a computed tomography (ct) that revealed air in the right side of the face, limited air in the right upper neck, and trace of air in the right chest.The patient was admitted to the hospital for one night on high-flow oxygen to facilitate quick air absorption.The physician reported that the patient did not have any infection but received prophylactic intravenous (iv) antibiotics while she was in the hospital.The patient was transition augmentin as an outpatient.The physician reported that the patient recovered well with all symptoms resolved.There was no permanent injury suffered.The hybrid procedure performed was done prior to the eustachian tube dilation procedure.The physician reported that the patient underwent an excision of a left lower neck lymphangioma.A drain was placed in the neck and the wound was closed.The eustachian tube dilation procedure was performed uneventfully without resistance or bleeding.A single dilation at 12 atm was performed bilaterally for two minutes.Tympanostomy tubes were placed.There were no known procedural complications associated with the use of the aera eustachian tube balloon; the balloon operated without any malfunction.The balloon was discarded and is thus not available for return.

• Brand Name: ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK
• Type of Device: UNKNOWN
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 92618
• Manufacturer (Section G): ACCLARENT, INC.; 33 technology drive; irvine 92618
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine 92618 ; 949789-868
• MDR Report Key: 7704854
• MDR Text Key: 114538828
• Report Number: 3005172759-2018-00110
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031230880
• UDI-Public: 10705031230880
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EU061655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1