Description of Event or Problem · 1
THE VALVE/CONDUIT GRAFT WAS OPENED ON THE FIELD FOR USE IN AORTIC VALVE AND ARCH REPAIR. EYE CAUTERY PROVIDED WITH THIS VALVE/CONDUIT WAS UTILIZED TO MAKE "BUTTON HOLE" IN GRAFT TO ANASTAMOSE THE GREAT VESSELS TO THE GRAFT. POSITION OF DESIRED BUTTONHOLE WAS MARKED ON THE GRAFT WITH STERILE SKIN MARKER. THE EYE CAUTERY WAS ACTIVATED TO "BURN" (MELT) GRAFT FIBERS AND CREATE OPENING SO THE FABRIC OF THE GRAFT DOES NOT FRAY. THIS IS STANDARD PROCEDURE. IN THIS CASE, THE GRAFT CONTINUED TO MELT BACK AND THE HOLE ENLARGED AFTER THE EYE CAUTERY WAS DEACTIVATED AND REMOVED FROM THE GRAFT. THERE WAS NO FLAME BUT SOME SMOKE. WHEN THE EXOTHERMIC PROCESS DID NOT STOP, THE SURGICAL TECH FLOODED THE VALVE/CONDUIT WITH SALINE (WHICH STOPPED THE REACTION) AND THE PRODUCT WAS REMOVED FROM THE FIELD. THE VALVE/CONDUIT, EYE CAUTERY, AND PACKAGING WERE SEQUESTERED FOR ANALYSIS. A SINGLE VALVE SUTURE WAS DAMAGED AND REPLACED. A DIFFERENT BRAND OF VALVE/CONDUIT WAS SIZED AND OPENED FOR USE WITHOUT INCIDENT. A DELAY OF NO MORE THAT 10 MINUTES WAS INCURRED AND THE PATIENT SUFFERED NO INJURY.======================MANUFACTURER RESPONSE FOR VALVE/CONDUIT GRAFT, CARBOMEDICS CARBO-SEAL VALSALVA GRAFT (PER SITE REPORTER).======================THEY ASKED IF THE VALVE/CONDUIT HAD BEEN IMMERSED IN SALINE BEFORE USE OF THE EYE CAUTERY AS THAT IS THE PROCESS OUTLINED IN THEIR DIRECTIONS FOR USE. IT WAS NOT; HOWEVER, IT IS NOT IN THE EXPERIENCE OR MEMORY OF ANY OF THE CVOR (CARDIOVASCULAR OPERATING ROOM) STAFF THAT THIS PARTICULAR PRODUCT (OR ANY OTHER) HAS BEEN INSERVICED WITH THAT DIRECTION. PAST PRACTICE FOR THOSE INTERVIEWED DOES NOT REVEAL THIS IMMERSION BEING DONE IN THE PAST. THE REPRESENTATIVE WILL REPLACE THE PRODUCT WITHOUT COST.