|
Model Number M00534210 |
Device Problems
Break (1069); Positioning Failure (1158)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/14/2023 |
Event Type
malfunction
|
Event Description
|
It was reported to boston scientific that an advanix biliary stent and naviflex rx delivery system was selected for use in the common hepatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During the procedure, the guide catheter could not be withdrawn, and the stent could not be deployed.The advanix biliary stent and naviflex rx delivery system were removed from the patient, and the procedure was completed with another advanix biliary stent.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 finding of guide catheter break.Please see block h10 for full investigation details.
|
|
Manufacturer Narrative
|
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter break.Block h10: the returned advanix biliary stent with naviflex rx delivery system was analyzed, a visual evaluation noted that the guide catheter was detached from the distal section and the stent remained attached to the naviflex rx delivery system.The pull wire was found fully retracted.The reported event of stent did not deploy was confirmed.Based on all the gathered information and product analysis, the investigation concluded that most likely the reported event and observed problems were most likely due to operational factors encountered during the procedure.Stent deployment technique and/or excess of force applied during pull wire retraction may result in friction between the push catheter and guide catheter.This may have caused the detachment of the guide catheter.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.
|
|
Search Alerts/Recalls
|
|
|