It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) cholangioscopy with electrohydraulic lithotripsy (ehl) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, after this device was passed in and out of the endoscope for several times, it was found that the tip got separated.The procedure was completed with a second spyscope digital access and delivery catheter.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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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