Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during an esophageal dilatation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was inflated to the highest setting; however, the balloon burst and deflated.The device was removed from the scope, and it was noticed that balloon portion was completely separated.Reportedly, no portion of the balloon detached into the patient.The procedure was completed with another cre fixed wire dilatation balloon.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
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