|
Model Number M00534710 |
Device Problems
Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/30/2023 |
Event Type
malfunction
|
Event Description
|
It was reported to boston scientific that an advanix biliary stent was attempted to be used to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure, performed on (b)(6) 2023.During the procedure, there was no resistance during the release of the stent.The stent did not appear to be attached to the system.The procedure was successfully completed with a new advanix biliary stent.The procedure was completed and there were no reported patient complications.Investigation results revealed that the guide catheter was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.
|
|
Manufacturer Narrative
|
Block h6: imdrf device code a150203 captures the reportable investigation results of guide catheter detached/separated.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached, and the detached section has evidence of tension forces being applied.The stent was returned attached to the guide catheter.The reported event of the stent being difficult to deploy can be confirmed.Taking all available information into consideration, most likely this was caused by an excess of force applied to the device during the stent deployment attempt.Based on the product analysis, the guide catheter was detached the stent was returned attached to the guide catheter.A microscopic inspection noted that the detached section of the guide catheter has evidence of tension forces applied.Therefore, the most probable cause is adverse event related to the procedure.
|
|
Search Alerts/Recalls
|
|
|