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

Model Number BC0716RU

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/17/2018

Event Type  malfunction  

Event Description

Balloon used for sinuplasty busted while in use on initial inflation.

• Brand Name: RELIEVA ULTIRRA
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT, INC. ; cr; OR
• MDR Report Key: 7525332
• MDR Text Key: 108723534
• Report Number: MW5077280
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031200289
• UDI-Public: 0110705031200289
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2019
• Device Model Number: BC0716RU
• Device Lot Number: 170904A-PC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 61