(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
|
It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex duodenal stent was to be implanted to treat an approximately 10 cm pancreatic cancer stricture in the duodenum during a duodenal stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the physician believed that the stent was deployed correctly inside the patient.However, when the scope was pulled out from the patient, the stent was deployed inside the scope.Reportedly, the procedure was cancelled and rescheduled on (b)(6) 2020 as another stent was not available on-site the day of the original procedure.There were no patient complications reported as a result of this event.
|