Description of Event or Problem · 1
PATIENT HAD JUST HAD A RIGHT CAROTID ARTERY ENDARTERECTOMY. HE DID WELL AND WAS AROUSED FROM ANESTHESIA AND WAS SPEAKING AND MOVING ALL EXTREMETIES WHEN HE BEGAN TO BLEED COPIOUS AMOUNTS IN THE NECK. PRESSURE WAS PLACED AND THE PATIENT WAS, ONCE AGAIN, SEDATED AND UNDERWENT ANESTHESIA. THE WOULD WAS QUICKLY OPENED AND IT WAS IDENTIFIED THAT THE SUTURE OF GORE-TEX HAD BROKEN. THE AREA IN QUESTION APPEARED TO BE QUITE A BIT CEPHALED TO THE MID KNOT THAT WAS TIED FROM THE SUTURES, BEGINNING ON EITHER END OF THE ARTERIOTOMY. THE CAROTID ARTERY WAS CLAMPED AND THE SUTURE IN THIS AREA WAS UNRAVELED FOR TWO OR THREE TURNS TO GIVE A LONG ENOUGH PIECE TO TIE. THE AREA WAS THEN IRRIGATED. THERE WAS MINIGAL BACKBLEEDING FROM THE INTERNAL CAROTID ARTERY. HOWEVER, THIS WAS THOUGHT TO BE DUE TO THE FACT THAT THE PATIENT WAS, AT THIS TIME, IN SHOCK. A NEW PORTION OF GORE-TEX WAS PLACED AND TIED TO THE UNRAVELED END CEPHALAD AND THEN CONTINUED DOWNWARD AND TIED TO THE UNRAVELED END DISTALWARD. FLOW WAS RE-ESTABLISHED AND THERE WAS PULSATILE FLOW PRESENT THROUGH THE COMMON CAROTID INTO THE INTERNAL CAROTID ARTERY. THE WOUND WAS THEN CLOSED LOOSELY WITH SILK AND VICRYL ALONG WITH SKIN STAPLES. PATIENT WAS TRANSFERRED TO THE ICU AND EXPIRED 10 DAYS LATERDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: DEVICE FAILED JUST PRIOR TO USE, DEVICE FAILURE RELATED TO PATIENT CONDITION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.