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

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Acclarent was notified on (b)(6) 2014 of an event during a sinus dilation case when acclarent balloon dilation tech were used.Physician reported that during a recent balloon sinuplasty procedure, a pt's lamina papyracea may have been fractured unintendedly due to blood visualized in the corner of the pt's eye.The physician is unclear if the balloon or acclarent's sinus guide catheter caused the fracture.The pt is fine and did not have any consequences from the operation.

Manufacturer Narrative

Based on the event description, the treating physician was not certain that an acclarent instrument caused the fracture.Acclarent made attempt two times to contact the treating physician to request additional info but did not get any responses.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 SYS
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT, INC.; menlo park CA
• Manufacturer Contact: isabel nielson, sr mgr ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 3889121
• MDR Text Key: 4424915
• Report Number: 3005172759-2014-00015
• 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
• Report Date: 05/15/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 06/11/2014
• 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 SINUS GUIDE CATHETER UNK
• Patient Outcome(s): Other