MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-19 for ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK EU061655 manufactured by Acclarent, Inc..
[114538828]
(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.
Patient Sequence No: 1, Text Type: N, H10
[114538829]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2018-00110 |
| MDR Report Key | 7704854 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-19 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-06-29 |
| Date Mfgr Received | 2018-06-29 |
| Date Added to Maude | 2018-07-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | ACCLARENT, INC. |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK |
| Generic Name | UNKNOWN |
| Product Code | LRC |
| Date Received | 2018-07-19 |
| Catalog Number | EU061655 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-19 |