This will be filed to report a material separation.It was reported that during device prep of a mitraclip procedure, the cap to the flush port on the delivery catheter handle would not screw on due to the threading.Subsequently, the device was exchanged and the procedure was completed without further reported complication.There was no clinically significant delay in the procedure and no patient involvement.The device was returned for analysis and a material separation was found.No additional information was provided.
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The reported broken dc handle flush port was confirmed during returned device analysis.The reported unstable cap could not be replicated in a testing environment due to the condition of the device (flush port was broken).Additionally, it was observed that the loctite fillet was not present on the area inside of the top flush port.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported dc handle flush port break resulting in unstable cap is due to missing loctite.The missing loctite is due to missed steps during manufacturing (man), as investigated in exception action.Corrective action will be implemented in the future to address this issue by improving the station layout and procedure.Abbott will continue to trend the performance of these devices.
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