Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not expired.(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.(b)(4).
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It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a gastroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the black endoscopic marker crumpled and detached from the catheter.After the procedure was completed, the balloon was withdrawn from the scope.The black endoscopic marker was noted to be left inside the patient and was retrieved using a grasping forceps.The procedure was completed at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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