It was reported to boston scientific corporation that a wallflex esophageal stent was to be used in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the deployed stent would not come of the catheter.So the physician pulled out the delivery system along with the stent.Due to unavailability of the same device, the procedure was rescheduled.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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The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Reported event of catheter difficult to remove.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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