MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA FLEX SINUS GUIDE CATHETER; FLEX GUIDE CATHETER

Catalog Number GC110RF

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/06/2014

Event Type  malfunction  

Event Description

Acclarent was notified on (b)(6) 2014, of an domestic event that occurred on (b)(6) 2014 during a sinus surgical cse when acclarent balloon dilation technology was used.The blue guide catheter tip came off during the procedure.The tip was retrieved very easily.There was no pt injury.

Manufacturer Narrative

Complaint device arrived on (b)(6) 2014 and failure analysis was performed on (b)(6) 2014.The returned package included a flex guide catheter m-110.The blue tip was detached from the guide catheter and it was inside the plastic container.Delamination damages were found inside the tip.There were scratches and pinches around distal of linear and blue tip area.There was material known as the nylon material between linear and nylon section which was peeling off from the pebax.Based on the investigation results, it is suspected that the damage could be the result of user used excessive force to manipulate the guide catheter.Acclarent will continue to monitor this phenomenon for trending purposes.This report is being submitted in an abundance of caution.

• Brand Name: RELIEVA FLEX SINUS GUIDE CATHETER
• Type of Device: FLEX GUIDE CATHETER
• Manufacturer (Section D): ACCLARENT, INC.; menlo park CA
• Manufacturer Contact: monica barret ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874948
• MDR Report Key: 3907046
• MDR Text Key: 4488224
• Report Number: 3005172759-2014-00004
• Device Sequence Number: 1
• Product Code: KAM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: GC110RF
• Device Lot Number: 120413D-CM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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