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

Model Number 1921002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Infiltration into Tissue (1931)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: analysis results not available; the device was not returned for evaluation.

Event 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.".

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HYDRODEBRIDER® FRONTAL HANDPIECE
• Type of Device: IRRIGATOR, POWERED NASAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 6412900
• MDR Text Key: 70252280
• Report Number: 1045254-2017-00086
• Device Sequence Number: 1
• Product Code: KMA
• UDI-Device Identifier: 00613994712608
• UDI-Public: 00613994712608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 98