While the exact cause is unk, in light of what was reported we believe it is highly unlikely that the device was the root cause of the event.During a f/u visit to the hosp our company rep was informed that staff does not believe that the airseal ifs system was the cause of the condition.The system has been employed in over (b)(4) cases and there have been no other reports of tension pneumothorax associated with the use of the system.While we are told that it is unlikely that a user facility report will be submitted to fda, the company has taken a proactive position in reporting to the agency.The company continues to monitor the clinical use of airseal ifs in accordance with the company policy and procedures and works diligently to improve product safety and design as part of the company's commitment to continous improvement.
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