MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA TRACT; BALLOON, NASAL AIRWAY

Model Number	RT1640A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Sinus balloon popped during inflation in patient around pressure of 10 atm.

• Brand Name: RELIEVA TRACT
• Common Device Name: BALLOON, NASAL AIRWAY
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology dr; irvine CA 92618
• MDR Report Key: 19475871
• Report Number: 19475871
• Device Sequence Number: 6932827
• Product Code: QGK
• UDI-Device Identifier: 10705031462649
• UDI-Public: (01)10705031462649
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/16/2024
• Report Date (Section F): 05/16/2024

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
• Device Model Number: RT1640A
• Device Catalogue Number: RT1640A
• Device Lot Number: 221129A-PC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White
• Date Report Sent to FDA: 05/16/2024