Acclarent was notified on (b)(4) 2014, of an domestic event that occurred on (b)(6) 2014 during a sinus surgical case when acclarent balloon dilation technology was used.The first two attempts to access the maxillary sinus with the guide catheter were successful with no issue.On the third attempt to access maxillary sinus, the blue tip of m-90 flex guide catheter fell off.There was no pt injury and the blue tip was retrieved.
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Complaint device arrived on (b)(4) 2014 and failure analysis was performed on (b)(6) 2014.The returned package included: one flex guide catheter m-90.The blue tip was detached from the guide catheter and it was inside the plastic bag.Upon inspection under the microscope, delaminating 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.
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