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 Code	Unspecified Ear or Labyrinth Problem (4474)
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from an internet related source.It was reported by hcp that he has seen an incidence of patulous in children when using the acclarent aera device.No further clarification on the incident(s) was provided.There are no reported malfunctions with any acclarent devices.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Information regarding patient date of birth, age, gender, weight, race, and ethnicity were not provided.Section b3: date of event: the date of the event was not reported.Section d.4: the expiration date of the device is not known as the device lot number is not available: not reported.Section h.4: the device manufacture date is not known as the device lot number is not available: not reported.The device was not returned for analysis; 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 may require 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.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.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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• 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: 18670848
• Report Number: 3005172759-2024-00007
• Device Sequence Number: 7128898
• 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): 02/08/2024

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: Not provided
• Initial Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown