MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. NUVENT¿; INSTRUMENT, ENT MANUAL SURGICAL

Model Number	18INFKIT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Endoscopic sinus surgery- frontal balloon sinusotomy.Attempted navigated balloon dilation without success due to medtronic frontal balloon malfunction ¿ the balloon would not fully inflate.Surgeon attempted troubleshooting multiple times ¿ instrument unable to complete task.Manufacturer response for instrument, ent manual surgical, nuvent ¿ (per site reporter).No response as of yet.Manufacturer response for instrument, ent manual surgical, nuvent¿ (per site reporter).No response as of yet.

• Brand Name: NUVENT¿
• Common Device Name: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 19446456
• Report Number: 19446456
• Device Sequence Number: 3240374
• Product Code: LRC
• UDI-Device Identifier: 00643169770997
• UDI-Public: (01)00643169770997(17)250403(10)0227525287
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/31/2024
• Report Date (Section F): 05/31/2024

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: 18INFKIT
• Device Catalogue Number: 18INFKIT
• Device Lot Number: 0227525287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2024
• 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: 26 DA
• Patient Sex: Female
• Patient Race: White
• Date Report Sent to FDA: 05/31/2024