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

Catalog Number	EU061655
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Syncope/Fainting (4411); Asystole (4442)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Since this adverse event requires 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.There are no reported malfunctions with any acclarent devices used during the case.Should additional information become available, this case will be re-assessed and notes will be updated.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.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 company is seeking this information through the event investigation.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.
Event or Problem Description
It was reported that a patient who underwent ent (ent (ear, nose & throat) procedure with acclarent devices (acclarent aera eustachian tube balloon dilation system) experienced a syncope episode and went into asystole during the procedure.It was reported that the event was confirmed by a physician-anesthesiologist with a heart rate monitor.It was also reported that the patient was revived with medication and oxygen.The procedure was aborted.The patient was reported to be in stable condition.It was also noted that the event occurred when the dilation system¿s balloon was dilated.

• Brand Name: ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM, 5PK
• Common Device Name: EUSTACHIAN TUBE BALLOON DILATION DEVICE
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19907764
• Report Number: 3005172759-2024-00084
• Device Sequence Number: 15237978
• Product Code: PNZ
• UDI-Device Identifier: 10705031230880
• UDI-Public: 10705031230880
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EU061655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown