Date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(4).Investigation results: a visual examination of the returned complaint device found that the balloon burst.It was also noticed that the catheter was kinked.Functional evaluation could not be performed due to the condition of the returned device.Dimensional examination of the catheter was performed and was measured in three sections; distal, medium and proximal.The three sections were within specification.Based on the available information, it is possible that factors encountered during the procedure, the technique used by the physician during the procedure, the amount of strength applied by the customer during the movement of the balloon, and/or the interaction between the scope and the balloon could have resulted in the damage found on the balloon.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during a dilation procedure performed in the esophagus on an unknown date.According to the complainant, during the procedure, an attempt to inflate the balloon was made; however, the balloon would not inflate.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be okay.Investigation results revealed that the balloon burst; therefore, this is now an mdr reportable event.
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