MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK EU061655 manufactured by Acclarent, Inc..
[142200775]
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.
Patient Sequence No: 1, Text Type: N, H10
[142200776]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2019-00120 |
| MDR Report Key | 8516699 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-03-16 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-04-15 |
| 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 | 31 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | ACCLARENT, INC. |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK |
| Generic Name | EUSTACHIAN TUBE BALLOON DILATION DEVICE |
| Product Code | PNZ |
| Date Received | 2019-04-15 |
| Catalog Number | EU061655 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-15 |