MAUDE Adverse Event Report: MEDTRONIC XOMED INC. HYDRODEBRIDER® FRONTAL HANDPIECE; IRRIGATOR, POWERED NASAL

Model Number	1921002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Infiltration into Tissue (1931)
Date of Event	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: analysis results not available; the device was not returned for evaluation.
Event or Problem Description
After using the fusion and nuvent¿ frontal sinus dilation balloon, the frontal sinuses were irrigated with the hydrodebrider.The patient presented with swelling of the conjunctival eyelids.Irrigation was stopped.The surgeon decompressed the patient's right eyelid and reduced the swelling by performing a lateral canthotomy, taking down the medial orbital wall.Since the swelling was pre-septal, the doctor believes that the entry of the saline was not related to the use of the nuvent or the sinus dissection, but believes that this patient, who has a history of facial trauma, had a preexisting dehiscence of the orbit that was too small to show up in the pre or post operative ct's that were taken.The patient has recovered; there are no complications.The surgery time was extended for one hour as the orbital decompression was added to the procedure, and an ophthalmologist was called in to assist.A postoperative ct confirmed there was no fluid in the brain or remaining in the right orbit.The surgeon confirmed that "the lateral canthotomy and medial orbital wall decompression were preventative.".
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: HYDRODEBRIDER® FRONTAL HANDPIECE
• Common Device Name: IRRIGATOR, POWERED NASAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6412900
• Report Number: 1045254-2017-00086
• Device Sequence Number: 637772
• Product Code: KMA
• UDI-Device Identifier: 00613994712608
• UDI-Public: 00613994712608
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2017

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 Expiration Date: 01/25/2020
• Device Model Number: 1921002
• Device Catalogue Number: 1921002
• Device Lot Number: 0212678328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 98