Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The reporter was unable to specify if the balloon was pre-inflated prior to advancement through the accessory channel of the endoscope.The instructions for use under system preparation states, "verify balloon integrity prior to use by attaching the enclosed syringe to stopcock and inflating balloon with air only.If any leakage is detected, do not use." in order to hold the balloon in an inflated state, the stopcock is placed in the closed position.To deflate the balloon the instructions for use state: "once balloon is endoscopically visualized in duodenum, turn stopcock to open position and deflate balloon." a kink in the catheter can contribute to balloon deflation difficulty by blocking the inflation lumen.This can occur if the extraction balloon receives excessive pressure during product handling or advancement through the endoscope.This activity will aid in device preservation.Prior to distribution, all fusion quattro extraction balloons are subjected to a visual and functionally tested to ensure device integrity.The functional test includes an air inflation test to ensure proper balloon function.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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