As reported one of the connectors detached from the balloon while being removed through the trocar.The sample evaluation confirms detachment of one of the connectors from the balloon.Regarding removal of the balloon the ifu prescribes that the user remove the balloon and trocar simultaneously.Based on the information provided and product evaluation the balloon connector appears to have detached from forces applied while removing the balloon through and not simultaneously with the trocar as prescribed in the ifu.Regarding the removal of the balloon the ifu states, "begin removal of the echo ps¿ positioning system by grasping one of the two removal points marked by the dark arrows adjacent to the bard® logo.Begin pulling the positioning system off the mesh in one smooth motion.Continue removing the echo ps¿ positioning system, pulling it up to the tip of the trocar.Remove both the echo ps¿ positioning system and trocar simultaneously.Verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact, discard the echo ps¿ positioning system appropriately." no lot number has been provided; therefore a review of the manufacturing records could not be performed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Due to privacy laws in (b)(4), the customer has not provided any patient details.
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