Concomitant medical product: boston scientific alliance inflation handle.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.There was a photo attached with the lot number said to be involved in the report.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusions: 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 stated the balloon was not lubricated prior to advancement through the accessory channel of the endoscope.A possible contributing factor to balloon damage is inadequate lubrication of the balloon with a lubricating agent.The instructions for use direct the user to "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in endoscopic advancement and balloon preservation.The reporter stated negative pressure was not applied to the balloon device prior to advancement through the accessory channel of the endoscope.Another possible contributing factor to balloon damage is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.The instructions for use direct the user "to facilitate passage through the endoscope, apply negative pressure to the catheter." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.Damage to the balloon material can occur if the balloon is inflated prior to advancement through the endoscope or if the balloon is inflated while partially or fully inside the accessory channel of the endoscope.The instructions for use contain the following precaution: ¿do not pre-inflate the balloon.¿ the instructions for use contain the following warning: ¿during dilation, do not inflate balloon beyond the maximum indicated inflation pressure.¿ over inflation can cause damage to the balloon dilator.Another possible contributing factor is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in damage to the balloon material.Prior to distribution, all hercules 3 stage balloon esophageal are subjected to a visual examination to ensure device integrity.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.Additional comments regarding this report: based on the information provided, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
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During an esophageal stricture dilation, the physician used a cook hercules 3 stage balloon esophageal.The product did not fill properly and water flew out of two holes.As per information from the cook representative: "balloon was introduced and inflation of the balloon did not work.Balloon was withdrawn from the endoscope and tested.When balloon was inflated, there were two jets of water from the balloon.Another balloon was used to complete the procedure." (b)(4).
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