It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the physician noticed that there was a leakage coming from the working channel of the device.The procedure was still completed with this device.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 good.Based on the photo received on (b)(6) 2018, the working channel sleeve protruded.
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