It was reported to boston scientific that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6) 2023.During the procedure and inside the patient, the stent failed to deploy.Another flexima biliary stent was opened and used to successfully complete the procedure.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.This event has been deemed a reportable event based on the investigation results; guide catheter detached/separated.Please see block h10 for full investigation detail.
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Bock h6: imdrf device code a0401 captures the reportable investigation result of guide catheter detached/separated.Block h10: the returned flexima biliary stent was analyzed, and a visual evaluation noted that the stent was attached to the delivery system with the guide catheter detached, and the push catheter suture hole was torn.After disassembling inspection, the guide catheter was pulled from the distal section and it was found detached.No other problems with the device were noted.The reported event of stent failure to deploy was confirmed.Based on all gathered information, the failures could have been caused by operational factors such as the deployment technique of the stent, and excess force applied during the retraction of the pullwire, which has caused friction between the push catheter and guide catheter, causing for the push catheter to be torn and the guide catheter detachment.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.
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