MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN SINUPLASTY SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

The patient was report to have been a female in her mid-60's, weight unknown.The acclarent products used during the procedure were said to have functioned as normal and the procedure was completed as planned.The physician noted that he was unsure of the cause of the cracked orbital bone.No acclarent devices are available to be returned for evaluation as they were discarded by the user facility.If additional information is received regarding this report, a supplemental report will be filed.Acclarent will continue to monitor this phenomenon for trending purposes.

Event Description

Acclarent was informed of an event in which a patient was said to have swollen eyes, a headache, and blurry vision in the left eye the day after a balloon sinuplasty (bsp) procedure of all sinuses, performed using an acclarent relieva spin 6x16 sinuplasty system.The reporting physician stated that the bsp procedure went as planned with no complications noted.The day following the procedure, the patient was said to have returned to the physician's office complaining of a headache, blurry vision in the left eye, and her eyes were said to have been swollen almost shut.It was reported that the patient was referred to an eye doctor and also to get a ct scan.The outcome of the visit with the eye doctor is unknown.The patient was reported to have had a cracked orbital bone based on the ct scan.It is not known if any intervention was taken to treat the cracked orbital bone.It was reported that by (b)(6) 2015, the patient was said to have been doing well, the swelling had reduced, and the vision had returned to normal.

• Brand Name: RELIEVA SPIN SINUPLASTY SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497899383
• MDR Report Key: 5323742
• MDR Text Key: 34258694
• Report Number: 3005172759-2015-00019
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RS0616MFS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention