MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA ULTIRRA; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number BC0616RU

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

During sinus surgery, the sinus balloon ruptured.No patient injury resulted.

• Brand Name: RELIEVA ULTIRRA
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 1525-b o¿brien park drive; menlo park CA 94025
• MDR Report Key: 4673684
• MDR Text Key: 5610535
• Report Number: 4673684
• Device Sequence Number: 0
• Product Code: LRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: BC0616RU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2015
• Patient Sequence Number: 1
• Patient Age: 34 YR