MAUDE Adverse Event Report: ACCLARENT INC. RELIEVA SINUS BALLOON CATHETER SYSTEM

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

Patient Problems Headache (1880); Hematoma (1884)

Event Type  Injury  

Event Description

Acclarent was notified on (b)(4) 2014 of an event involving a pt with cystic fibrosis complaining of headache and post-surgical complications within a week after having sinus surgery in a hosp.The physician called to report that a pt with cystic fibrosis came to see him within a week of having sinus surgery in the hosp with another ent doctor.Based on the operating physician's operative notes, an acclarent balloon was used to dilate the frontal sinus and irrigated with vortex.The pt came in to see the physician post operatively complaining of headache and post-surgical complication.After evaluation, it was determined that the pt had developed a hematoma in the frontal sinus with a possible dehiscence of the posterior table of the frontal.The pt has had multiple sinus surgeries in the past, so it is unclear whether the dehiscence was present before the surgery.The physician was also unclear whether the balloon played a part in the post-operative complication or not, as he was not the operating surgeon.

Manufacturer Narrative

There is insufficient info to determine if the acclarent devices caused the hematoma and posterior wall dehiscence.In view of the multiple operations and history of cystic fibrosis, it is impossible to know what caused the dehiscence.While the acclarent devices were used for surgery, there is not enough info to determine if they caused the problem.It would have been helpful to know whether there was any medical or surgical treatment needed because of the headaches and posterior wall dehiscence.A supplemental report will be submitted if additional info is received.Acclarent will continue to monitor this phenomenon for trending purposes.

• Brand Name: RELIEVA SINUS BALLOON CATHETER 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: 3876385
• MDR Text Key: 4594536
• Report Number: 3005172759-2014-00014
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 IRRIGATION CATHETER. UNK