MAUDE Adverse Event Report: ACCLARENT RELIEVA SPIN ABLLOON SINUPLASTY SYSTEM; SINUS BALLOON CATHETER

Model Number NS

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

Patient Problem Swelling (2091)

Event Date 12/19/2014

Event Type  Injury  

Event Description

Acclarent was informed of an event in which a patient developed significant swelling around the left eye during a surgical procedure in which an acclarent relieva spin balloon sinuplasty system had been used.During the primary bilateral maxillary sinus procedure, the surgeon attempted to access the patient's left maxillary sinus with a relieva spin balloon sinuplasty system, but was unsuccessful.The balloon on the catheter was not inflated, and the spin system was removed from the patient's anatomy.The surgeon elected to convert the procedure to a traditional functional endoscopic sinus surgery (fess) procedure, and proceeded to use a shaver to remove ethmoid cells.Sometime thereafter, the patient was noted to have significant swelling around the left eye.User facility personnel reportedly provided "intervention" to the patient; however, the facility did not provide details as to what type of intervention was provided to address the swelling.The facility staff indicated that the patient "was doing fine" following the procedure, but no other details related to the event were provided.

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 relieva spin balloon sinuplasty system did not identify any anomalies.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 ABLLOON SINUPLASTY SYSTEM
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT; menlo park CA
• Manufacturer Contact: izabel nielson, sr. manager ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4425684
• MDR Text Key: 17933106
• Report Number: 3005172759-2015-00002
• 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: 12/19/2014

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: 10/10/2017
• Device Model Number: NS
• Device Catalogue Number: RS0616F
• Device Lot Number: 141010A-CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: SHAVER: UNK TYPE
• Patient Outcome(s): Required Intervention