OPTISITE ARTERIAL CANNULA

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED. PER THE PRELIMINARY EVALUATION OF THE DEVICE, A KINK WAS IDENTIFIED AT THE BASE OF THE CANNULA. IN ADDITION, SOME SMALLER KINKS WERE IDENTIFIED CLOSE TO THE TIP. THE SUTURE RING WAS NOT EASY TO MOVE ALONG THE CANNULA. MODERATE FORCE WAS REQUIRED TO MOVE THE SUTURE RING. THIS INVESTIGATION IS IN PROGRESS. FURTHER FINDINGS AND CONCLUSIONS WILL BE REPORTED IN A TIMELY MANNER AS ADDITIONAL INFORMATION BECOMES AVAILABLE. IN THIS CASE, THERE WAS NO INJURY TO THE PATIENT NOTED. ENABLECV, LLC WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Description of Event or Problem

IT WAS REPORTED THAT AN OPTI20 HAD TO BE EXCHANGED DURING THE PROCEDURE, REQUIRING AN INTERRUPTION TO BYPASS. REPLACEMENT PRODUCT WAS WITH AN OPTI20 FROM THE SAME LOT. AN IMAGE WAS PROVIDED. IT WAS REPORTED THAT THE PLASTIC SLIDER PIECE WAS TOO LARGE FOR THE CANNULA. IT SLID FREELY AND THE CANNULA NEARLY DISLODGED FROM THE AORTA. PER ADDITIONAL INFORMATION, THE SURGEON SAID IT WAS HIS FAULT FOR THE CANNULA 'SLIPPING' STATING HE DID NOT PURSESTRING IT TIGHT ENOUGH. THEY SAID EVERYTHING WORKED OUT AFTER PLACING A SECOND CANNULA AND MAKING SURE IT WAS SECURED WELL. THEY FIRST NOTICED THE SLIPPING/ SLIDING AFTER THE PURSESTRING WAS IN PLACE. THE DEVICE WAS REPLACED 1-2 MINUTES INTO THE PROCEDURE. THERE WAS NO DAMAGE TO THE PATIENT/ VESSEL DUE TO THE DEVICE NOT BEING SECURED. THE PATIENT HANDLED THE EXCHANGE WELL AND NO OTHER IMPACT TO THE PATIENT WAS NOTED. NO MEASURABLE BLOOD LOSS DUE TO THE EVENT REPORTED.