MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN BALLOON SINUPLASTY SYSTEM; SINUS BALLOON CATHETER

Catalog Number RS0516F

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

Patient Problem Swelling (2091)

Event Date 07/01/2014

Event Type  Injury  

Event Description

Acclarent was informed that while irrigating the patient's maxillary sinuses with an olive tip suction catheter following a balloon dilation procedure in which the subject device of this report was used, the eye and periorbital tissues began to swell and irrigation was stopped.The physician immediately performed a lateral canthotomy and cantholysis and then decompressed the lamina papyracea on the side of the swelling via an endoscopic ethmoidectomy to relieve the pressure from the globe.An eye exam was performed on the patient following recovery from anesthesia, and the patient was immediately sent to ophthalmology for a complete eye exam.The patient's eye exam result was reported to be 20/20 vision, with no ophthalmologic abnormalities such as double or blurred vision, or vision loss.

Manufacturer Narrative

The device reference in this report was not returned for evaluation as it was discarded by the user facility.The user did not report any difficulty associated with the operation of device during or after the procedure.A supplemental report will be submitted if additional information is received, and acclarent will continue to monitor this phenomenon for trending purposes.

• Brand Name: RELIEVA SPIN BALLOON SINUPLASTY SYSTEM
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT, INC.; menlo park CA
• Manufacturer Contact: izabel nielson, sr. mgr., ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4017313
• MDR Text Key: 4877073
• Report Number: 3005172759-2014-00017
• 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
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RS0516F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OLIVE TIP SUCTION; FREER ELEVATOR; BALL TIP SEAKER
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR