We have received the complaint device for evaluation and we have confirmed the reported incident.We observed a leakage at the blue stopcock joint when we attempted to inject liquid into the common carotid balloon.As a result, the common carotid balloon failed to inflate.Upon further inspection of the joint, we observed an inadequate amount of glue at the stopcock joint.The internal carotid balloon inflated and deflated properly.The root cause of the malfunction was determined to be a manufacturing operator error- not enough glue was applied on the stopcock joint during the assembly process.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.We have implemented a corrective and preventive action (capa) to address this issue and prevent them from reoccurring.The corrective action includes retaining and qualifying operators for the gluing operations.The malfunction was detected during the pre-use check.This device was not used for the procedure.
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