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	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During septoplasty portion of surgery, sinus balloon popped at a pressure of 4atm, manufacturer¿s reported pressure max should be at 8atm, patient uninjured.

• Brand Name: RELIEVA TRACT
• Common Device Name: BALLOON, NASAL AIRWAY
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; ste 200; irvine CA 92618
• MDR Report Key: 18844977
• Report Number: 18844977
• Device Sequence Number: 7832362
• 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): 02/22/2024
• Report Date (Section F): 02/22/2024

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 Model Number: RT1640A
• Device Catalogue Number: RT1640A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White
• Date Report Sent to FDA: 02/22/2024