MAUDE Adverse Event Report:

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Event Description

Acclarent became aware of an event submitted on www.Balloonsinuplasty.Com.The event occurred during a procedure in which an unk balloon sinuplasty device was used.The pt reported having damaged nerve on the right ear after having a balloon sinuplasty procedure on the bilateral maxillary sinuses and frontal sinuses.The pt also had bilateral paper patch myringoplasty and bilateral eustachian tube dilation procedure.

Manufacturer Narrative

There are no evidence that the acclarent devices caused or contributed to the reported event.The post indicated that the pt had balloon sinuplasty procedure but there are many surgeons using balloon devices from different manufacturers and uses the same balloon sinuplasty terminology.If add'l info is received regarding the devices used in this event, a supplemental report will be filed.This report is being submitted in an abundance of caution.

• Brand Name: UNK
• Type of Device: UNK
• Manufacturer Contact: izabel nielson, sr. mgr. ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4240325
• MDR Text Key: 5012772
• Report Number: 3005172759-2014-00030
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention