Description of Event or Problem · 1
PATIENT PRESENTED WITH PROGRESSIVE EMESIS AND HEADACHE. CT SCAN REVEALED INCREASED VENTRICULAR CALIBER CONSISTENT WITH SHUNT MALFUNCTION, THEREFORE EMERGENT SHUNT REVISION WAS RECOMMENDED, WRITTEN CONSENT PROVIDED.THE PATIENT WAS BROUGHT TO SURGERY, AFTER INDUCTION OF GENERAL ANESTHESIA. THE OPERATION BEGAN, AFTER INCISE OF SKIN OVER THE RIGHT FRONTAL AND RETROAURICULAR INCISIONS, FOUND THE RICKHAM RESERVOIR WAS DETACHED FROM THE VENTRICULAR CATHETER. THERE WAS NO EVIDENCE OF CEREBROSPINAL FLUID DRAINAGE AT THIS POINT. ATTENTION WAS TURNED TO REPLACEING THE VENTRICULAR CATHETER. SPECIFICALLY, IT WAS NOTED AT THIS POINT THAT THIS WAS A BIOGLIDE CATHETER AND THE SNAP ON CUP HAD BECOME DISCONNECTED FROM THE VENTRICULAR CATHETER. REMOVING THE PLASTIC CUP, AND USING A HOOKED NEEDLE THE VENTRICULAR CATHETER WAS REMOVED. VENTRICULAR CATHETER WAS SOFT PASSED ON THE SAME TRACT WITH BRISK RETURN OF CEREBROSPINAL FLUID, WHICH WAS COLLECTED AND SENT FOR CEREBROSPINAL FLUID ANALYSIS. AFTER SURGERY THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM AND TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SPECIFICALLY, NOTED AT THIS POINT THAT THIS WAS A BIOGLIDE CATHETER AND THE SNAP ON CUP HAD BECOME DISCONNECTED FROM THE VENTRICULAR CATHETER. THIS IS A KNOWN PROBLEM AND THE MANUFACTURER IS AWARE OF THIS PROBLEM AND HAS ISSUED A RECALL ON THE BIOGLIDE CATHETER, (FDA RECALL #'S Z-1124-2009 TO Z-1134-2009).====================== MANUFACTURER RESPONSE FOR MEDTRONIC BIOGLIDE VENTRICULAR CATHETER, BIOGLIDE VENTRICULAR CATHETER======================THE MANUFACTURER IS AWARE OF THIS PROBLEM AND HAS ISSUED A RECALL ON THIS BIOGLIDE CATHETER, (FDA RECALL #'S Z-1124-2009 TO Z-1134-2009).