FLOSEAL MATRIX HEMOSTATIC SEALANT

Description of Event or Problem

DATE OF OCCURENCE: ESTIMATED FEB 2006. THE PATIENT WAS PRESENT AND SURGERY WAS SUCCESSFUL. EVENT DESCRIPTION: PATIENT UNDERWENT ANTERIOR CERVICAL DISC SURGERY (2 TO 3 LEVELS). APPROXIMATELY MIDWAY THROUGH THE CASE, THE ANETHESIOLOGIST STATED THAT THE PULSE OXIMETER READING HAD BEEN LOST AS WELL AS THE ARTERIAL LINE READING, BOTH IN THE RIGHT ARM. THE CIRCULATING NURSE CHECKED THE RIGHT ARM UNDER THE DRAPES. THE NURSE STATED THE ARM WAS COLD AND THERE WAS NO CAPILLARY REFILL. A VASCULAR SURGEON WAS ASKED TO COME IN AND EVALUATE THE ARM. THE CERVICAL DISC WAS COMPLETED, AND THE VASCULAR SURGEON PROCEEDED TO ENDOSCOPICALLY REMOVE A CLOT FROM THE RIGHT ARM. THE CLOT WAS SENT TO PATHOLOGY. THE SURGEON STATED THAT THE PATIENT DID NOT WAKE UP HOW SHE HAVE LIKED, AND LATER DURING HER RECOVERY THE PATIENT WAS FOUND TO HAVE INTRACRANIAL INFARCTS. THE PATIENT WAS ALSO FOUND TO HAVE A PATENT FORAMEN OVALE. THE PATHOLOGIST, REPORTED TO ANOTHER DR THAT THE CLOT HAD "CHARACTERISTICS SIMILAR TO FLOSEAL". THIS REPORT CONCERNED SECOND DR AND SHE FELT IT WAS IMPORTANT TO BRING IT TO THE ATTENTION OF BAXTER SECOND DR STATED THE PATIENT WAS IN A FLAT POSITION, AND THAT EACH TIME FLOSEAL WAS USED, IT WAS PLACED ONTO ACTIVE BLEEDING SITE.