MAUDE Adverse Event Report: ACCLARENT RELIEVA ULTIRRA SINUS BALLOON CATHETER

Catalog Number BC0161RU

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/29/2014

Event Type  malfunction  

Event Description

Acclarent was notified on (b)(4) 2014 of an event during a sinus surgical case when acclarent balloon dilation technology was used.The physician reported that the balloon had a hole in it.The device returned on (b)(4) 2014 and device investigation was performed on (b)(4) 2014.The return device investigation revealed that the blue tip was completely detached from the distal end of the catheter.The detached blue tip was returned with the catheter.

Manufacturer Narrative

Based on the investigation result, it is suspected that the damage could be the result of user used excessive force to manipulate the catheter.Acclarent will continue to monitor this phenomenon for trending purposes.This report is being submitted in an abundance of caution.

• 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: 3973079
• MDR Text Key: 4610669
• Report Number: 3005172759-2014-00013
• 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: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2015
• Device Catalogue Number: BC0161RU
• Device Lot Number: 131119E-CM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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