MAUDE Adverse Event Report: ACCLARENT INC RELIEVA SINUS BALLOON CATHETER SYSTEM

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

Patient Problem Swelling (2091)

Event Type  Injury  

Event Description

Acclarent was made aware of this event on (b)(4) 2014 when a literature search was being conducted by an acclarent employee.In the article, an unk type of 5mm acclarent sinus balloon with guide was used to dilate on the right maxillary sinus at 12 atm, then the physician performed irrigation of the sinus.While examining the left side, a sudden swelling of the entire right periorbital area including the upper and lower eyelids.Examination of the eye could not be preformed because of the swelling.An immediate subsidiary incision of the lower orbital rim incision was made.An ophthalmologist was called who found normal intraocular pressures with no visible damage to the orbital contents.Surgery was terminated and the left sinuses were not operated upon.Postoperative eye findings were within normal limits.A postoperative ct scan revealed a small fracture of the right infero-medial orbital wall not present in preoperative ct scan.

Manufacturer Narrative

Vp of medical affairs contacted the author if literature via the email to obtain additional information.As of (b)(4) 2014, he did not receive any response.Based on the information provided, vp of medical affairs concluded that acclarent sinuplasty devices contributed to the event of pre-septal orbital swelling and the swelling confined to the eyelids.There was no change in vision.Medical intervention with an orbital decompression performed via a subsidiary incision was needed to preclude permanent impairment of vision.Mdr will be updated if additional information become available.The subject device of this report was not returned for evaluation, and its whereabouts are unk.Acclarent will continue to monitor this phenomenon for trending purposes.This report is being submitted in an abundance of caution.

• Brand Name: RELIEVA SINUS BALLOON CATHETER SYSTEM
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT INC; menlo park CA
• Manufacturer Contact: izabel nielson ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 3731347
• MDR Text Key: 21531145
• Report Number: 3005172759-2014-00007
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR