Pma/510(k) # k163468.(b)(4).Problem statement: at preparation stage, operator want to confirm there is no issue of releasing the stent so that he checked the stent release before use while found out the stent cannot be released after pull the trigger.Operator confirmed that the red marker worked properly with no issue.Device evaluation: the evo-25-30-8-c device of lot number c1273067 was returned to cook (b)(4) and evaluated on the 17 jan 2018.Lab evaluation: upon evaluation of the returned device, the lockwire was still in place.Upon actuation, no deployment or retraction was possible.The red shuttle deployment marker was at the back half of the handle.There was no stent exposure on return.The device was dismantled during the lab, and the flexor was noted to be broken at the shuttle cap.The stent was manually deployed during the lab and there were no issues noted with the stent.Customer complaint confirmed as failure was verified in laboratory.The flexor was seen to be broken at the shuttle cap.Root cause: a possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath document review: prior to distribution all evo-25-30-8-c devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at (b)(4).A review of the qc records did not reveal any issues which could have contributed to this complaint issue.Ifu review: as per the instructions for use, which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Summary: customer complaint confirmed as failure was verified in laboratory.The flexor was seen to be broken at the shuttle cap.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.This event occurred prior to patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.
|