The exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.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 mdr will be filed.
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the bile duct during a retrograde catheterization of the bile ducts on an indeterminate stenosis procedure.According to the complainant, during the procedure, it was noticed that the distal tip of the spyscope ds detached.Reportedly, the patient's anatomy was not particularly tortuous or difficult.The procedure was still completed with a second spyscope digital access and delivery catheter.There were no patient complications reported as a result of this event.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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