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

Catalog Number BC0724RU

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/15/2014

Event Type  malfunction  

Event Description

Acclarent was notified on (b)(6) 2014 of a domestic event that occurred on (b)(6) 2014 during a sinus surgical case when acclarent balloon dilation technology was used.The physician experienced difficulty accessing the sinus while using ultirra balloon catheter with maxillary guide (110) due to tight infundibulum.During the procedure, the ultirra catheter tip detached completely in the patient's nasal cavity.An unknown instrument was used to retrieve the tip.There was no patient injury due to tip detachment.

Manufacturer Narrative

The tip was retrieved from patient at the time of surgery.There was no injury to the tissue from tip detachment.The subject device of this report was not returned for evaluation, and its whereabouts are unknown.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, INC.; menlo park CA
• Manufacturer Contact: izabel nielson, sr. manager ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 3830172
• MDR Text Key: 4501834
• Report Number: 3005172759-2014-00010
• 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: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2015
• Device Catalogue Number: BC0724RU
• Device Lot Number: 130912C-CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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
• Treatment: ACCLARENT MAXILARY GUIDE, 110