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

Catalog Number RS0616M

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

Patient Problem Swelling (2091)

Event Date 06/18/2014

Event Type  Injury  

Event Description

Acclarent was informed that swelling was observed around a patient's right eye following bilateral maxillary sinus dilation with lavage in a procedure in which an acclarent spin balloon sinuplasty system and vortex 2 irrigation catheter were used.The physician was concerned that the saline used during the lavage had infiltrated the orbital space and was the cause of the swelling, and performed an uncinectomy to inspect the right maxillary sinus.By applying pressure to the swollen area externally, the physician was able to identify a dehiscence area near the right orbital where saline was escaping.The physician continued to apply external pressure while suctioning near the dehiscence site.The swelling reportedly subsided and the procedure was concluded.The patient was said to be "fine' and did not have further sequelae from the operation.The physician reported that it is unclear if the dehiscence was created during the procedure or if it existed prior to the operation.

Manufacturer Narrative

The device referenced in this report was discarded and was not available for evaluation.The user did not report any difficulty associated with the operation of device during or after the procedure.The cause of the reported difficulty could not be conclusively determined.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: 3964848
• MDR Text Key: 16543803
• Report Number: 3005172759-2014-00016
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RS0616M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2014
• 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
• Treatment: ACCLARENT RELIEVA VORTEX 2 IRRIGATION CATHETER
• Patient Outcome(s): Required Intervention