MAUDE Adverse Event Report: ACCLARENT RELIEVA ULTIRRA SINUS BALLOON CATHETER

Catalog Number BC0616RU

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

Patient Problem Swelling (2091)

Event Date 08/07/2014

Event Type  Injury  

Event Description

Acclarent was informed that after primary dilation and irrigation of the left maxillary sinus, the pt's upper left eyelid began to swell.The physician made an incision in the eyelid to drain the fluid then sent the pt to the emergency room.The physician consulted with an ophthalmologist who evaluated the pt and confirmed no ophthalmologic abnormalities such as double or blurred vision, or vision loss.Pt was released and the physician followed up and pt was doing fine with no sequelae.There was no additional intervention or mgmt.

Manufacturer Narrative

The device referenced in this report was not returned for evaluation as it was discarded by the user facility.The user did not report any difficulty associated with the operation of device during or after the procedure.The med intervention may have been unnecessary based on the available info, but done for unk reasons.A supplemental report will be submitted if additional info is received, and acclarent will continue to monitor this phenomenon for trending purposes.

• Brand Name: RELIEVA ULTIRRA SINUS BALLOON CATHETER
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT; menlo park CA
• Manufacturer Contact: izabel nielson, sr mgr ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4101655
• MDR Text Key: 4839827
• Report Number: 3005172759-2014-00022
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111254
• 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: 08/07/2014

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 Catalogue Number: BC0616RU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR