The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.(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 wireguided dilatation balloon was used in the duodenum during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.According to the complainant, after the procedure, there was difficulty withdrawing the balloon through the endoscope.It was noted that the exit marker detached and was found in the scope.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 fine.
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