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

Catalog Number RS0616M

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

Patient Problem Swelling (2091)

Event Date 09/10/2014

Event Type  Injury  

Event Description

Acclarent was informed of an event that occurred during a procedure in which an relieva spin balloon sinuplasty system and an acclarent vortex 2 irrigation catheter device were used.The physician had difficulty accessing the right frontal sinus using the spin device and used an unidentified frontal seeker to access the sinus.After the physician successfully dilated the sinus, the physician began irrigating the right frontal sinus using an acclarent vortex 2 irrigation catheter.During irrigation, the physician observed orbital fat bulging into the right frontal sinus recess and the patient's right eye swelling and leaking saline.The physician made an incision into the right eyelid to reduce the pressure and drain the excess saline, and called for an ophthalmic surgeon.The ophthalmic surgeon tested the pressure in the patient's right eye and confirmed to be normal.The physician then removed a portion of the protruding orbital fat from the nasal cavity and sutured up the incision made on the right eyelid.Patient was said to be fine after the procedure.Patient follow up occurred the following week and showed the patient is doing well with no further sequelae reported.

Manufacturer Narrative

The subject device referenced in this report was discarded by the user facility and was not available for evaluation.Review of manufacturing records associated with the subject device did not detect any anomalies.The physician reported having no difficulties in using the acclarent 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 SINULASTY SYSTEM
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT, INC.; .; menlo park CA
• Manufacturer Contact: izabel nielson, sr. manager ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4151966
• MDR Text Key: 4786067
• Report Number: 3005172759-2014-00028
• 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
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2017
• Device Catalogue Number: RS0616M
• Device Lot Number: 140527A-CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: THERAPY DATE:; UNIDENTIFIED FRONTAL SEEKER
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR