FLOSEAL MATRIX HEMOSTATIC SEALANT

Description of Event or Problem

DR'S PATIENT HAD A TOTAL KNEE ARTHROPLASTY IN 2006. PER PA FOR DR, PATIENT HAD A TIA (TRANSIENT ISCHEMIC ATTACK). AUTOTRANSFUSION DRAIN PLACED. PATIENT HAS A HISTORY OF TIAS. FLOSEAL APPLIED WITH TOURNIQUET UP. ADDITIONAL INFORMATION RECEIVED 07-NOV-06: PA DOES NOT BELIEVE TIA TO BE CAUSED BY FLOSEAL, DUE TO PATIENT'S HISTORY.

Additional Manufacturer Narrative

BAXTER MEDICAL DIRECTOR ASSESSMENT: NOVEMBER 11, 2006: BASED ON THE NARRATIVE WE CANNOT RULE OUT THAT FLOSEAL AND ITS MISHANDLING HAVE CONTRIBUTED TO THE ADVERSE EVENT. A TRANSIENT ISCHEMIC ATTACK (TIA) IS CAUSED BY AN INTERRUPTION OF BLOOD FLOW TO BRAIN CELLS. IF THE SYMPTOMS RESOLVE COMPLETELY IN LESS THAN 24 HOURS, THIS IS CALLED A TIA OR "MINI STROKE." A BRIEF INTERRUPTION TO THE BLOOD FLOW CAN CAUSE A DECREASE IN BRAIN FUNCTION (NEUROLOGICAL DEFICIT). THE FOLLOWING CAN CAUSE THE LOSS OF BLOOD CIRCULATION TO THE BRAIN: NARROWING OF A BLOOD VESSEL. BLOOD CLOTTING WITHIN AN ARTERY OF THE BRAIN. BLOOD CLOT TRAVELING TO THE BRAIN FROM SOMEWHERE ELSE IN THE BODY (E.G., HEART). A BLOOD DISEASE, CANCER, AND OTHERS. INFLAMMATION OF BLOOD VESSELS. INJURY TO BLOOD VESSELS. IN A TIA, THE BLOOD SUPPLY IS ONLY TEMPORARILY BLOCKED. FOR EXAMPLE, A BLOOD CLOT MAY DISSOLVE AND ALLOW BLOOD TO FLOW NORMALLY AGAIN. GIVEN THE PATIENT'S HISTORY OF PREVIOUS TIAS, THE EVENT HAS BEEN PROBABLY CAUSED BY ALTERNATIVE CAUSES, OTHER THAN FLOSEAL. NEVERTHELESS, THE APPLICATION OF FLOSEAL IN A DRY AREA (TOURNIQUET ON) AND IN THE PRESENCE OF THE AUTOTRANSFUSION DRAIN PLACES, ARE FACTORS THAT MAY INCREASE THE RISK OF INTRAVASCULAR APPLICATION OF FLOSEAL. BESIDES OF THAT, IN ORDER TO WORK, FLOSEAL NEEDS FLOWING BLOOD (FIBRINOGEN) TO REACT AND STOP EVENTUAL BLEEDING. THE FLOSEAL IFU IS ADEQUATELY ADDRESSING ALL THESE RELEVANT SAFETY AND APPLICATION ASPECTS REFERRED IN THIS CASE. THE INSTRUCTION OF THE REPORTER'S PA THROUGH MEDICAL AFFAIRS WAS ADEQUATE. STILL, THE RELEVANT PERSON TO BE RETRAINED IS THE SURGEON, MD BIOSURGERY. RETRAINING/RE-EDUCATION DESCRIPTION: BAXTER RN, DISCUSSED WITH SURGEON PA, THE PRECAUTION OF USING AUTOLOGOUS BLOOD SALVAGE CIRCUITS WITH FLOSEAL. (PATIENT HAD AN AUTOTRANSFUSION DRAIN PLACED). ALSO DISCUSSED THE NEED FOR THE TOURNIQUET TO BE DOWN, AS FLOSEAL REQUIRES ACTIVE BLEEDING AND SHOULD NOT BE APPLIED TO A CLAMPED VESSEL, WHICH A TOURNIQUET WOULD STIMULATE. ALSO DISCUSSED THAT FLOSEAL SHOULD NOT BE COMPRESSED INTO BLOOD VESSELS. AFTER THE CONVERSATION, BASED UPON DISCUSSION (PER PHONE) THAT BAXTER RN, BAXTER SALES, HAD WITH PA EARLIER TODAY, HE SAID HE HAD NO FURTHER QUESTIONS. ADDITIONAL RETRAINING/RE-EDUCATION IS NEEDED WITH THE SURGEON WHO PERFORMED THE PRCOEDURE. A SESSION HAS BEEN SCHEDULED WITH DR THE WEEK OF DECEMBER 11TH. A FOLLOW-UP REPORT WILL BE SENT UPON ITS COMPLETION.