MAUDE Adverse Event Report: ACCLARENT 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 02/05/2014

Event Type  malfunction  

Event Description

Acclarent was notified on (b)(6) 2014 of an international event that occurred on (b)(6) 2014 during a sinus surgical case when acclarent balloon dilation technology was used.The physician tried to access the right maxillary sinus and there was a tight space with tissue edema that made it very difficult to position the guide catheter tip.He managed to rotate from tip down position at the uncinated process.Then, he moved to left maxillary sinus and there was a tight space also and he managed to rotate the guide catheter tip at the uncinate.The physician went back to the right maxillary sinus and when he managed to turn the guide catheter tip behind the uncinate process, the distal tip was tore off.The physician used rigid instruments to remove the distal tip from behind the pt's uncinate process.There was no pt injury.

Manufacturer Narrative

Complaint devices arrived on 02/11/2014 and failure analysis was performed on 02/12/2014.The returned package included a flex guide catheter m-110 and a 5x16mm balloon catheter.The following observations were note during eval: the flex m-110-guide catheter's blue tip was detached from the guide catheter.The blue tip was inside the returned bag.Upon inspection under the microscope, delamination damages were found inside the tip.There were scratches and pinches around distal of linear and blue tip area.The flex guide catheter was checked and there was material known as the nylon material between linear and nylon section which was peeling off from the pebax.The balloon catheter hypo tube was kinked near the white maker band.The catheter was tested by connected it to the sample inflation device, filled with water under pressure, the balloon was inflated to 12atm w/o losing pressure.The balloon did not leak during inflation and deflation.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; menlo park CA
• Manufacturer Contact: monica barrett ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874948
• MDR Report Key: 3745478
• MDR Text Key: 21530135
• Report Number: 3005172759-2014-00002
• Device Sequence Number: 1
• Product Code: KAM
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: NA
• 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: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2015
• Device Catalogue Number: GC110RF
• Device Lot Number: 130730E-CM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACCLARENT LUMA SENTRY GUIDEWIRE; ACCLARENT SOLO PRO BALLOON
• Patient Age: 6 YR