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 Codes	Crack (1135); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported during a eustachian tube dilation, when using an acclarent aera eustachian tube balloon dilation system, 5pk (eu061655, unknown lot) during a primary procedure on (b)(6) 2024 the "silver guide tip catheter was not properly sealed and was released from the orange plastic connector." the reporter stated the silver tip was "spinning" and was able to be pulled apart from the orange piece.It was noted that they replaced the balloon catheter and the issue resolved.No other issue was reported.No non acclarent devices were used.There was no allegation that a death or serious injury occurred due to the use of the product.The patient did not require any medical intervention as a result the alleged product issue.Additional information was received on 11-dec-2023 clarifying that the ¿"the silver guide tip" refers to the right shaft.The right shaft was not broken.
Additional Manufacturer Narrative
Product complaint # (b)(4).D.4: the expiration date of the device is not available at time of reporting.H.4: the device manufacture date is not available at time of reporting.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Based on the device received, the tip of the guide catheter is not partially separated.Therefore, the event does not meet us regulatory reporting criteria.

• 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 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18475154
• Report Number: 3005172759-2024-00004
• Device Sequence Number: 6407994
• Product Code: PNZ
• UDI-Device Identifier: 10705031230880
• UDI-Public: 10705031230880
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2025
• Device Catalogue Number: EU061655
• Device Lot Number: 230807B-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown