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

Model Number	BC0716RU
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon used for sinuplasty busted while in use on initial inflation.

• Brand Name: RELIEVA ULTIRRA
• Common Device Name: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT, INC. ; cr; OR
• MDR Report Key: 7525332
• Report Number: MW5077280
• Device Sequence Number: 1529046
• Product Code: LRC
• UDI-Device Identifier: 10705031200289
• UDI-Public: 0110705031200289
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2019
• Device Model Number: BC0716RU
• Device Lot Number: 170904A-PC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Weight: 61