6F ANGIO-SEAL EVOLUTION ST. JUDE MEDICAL

NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, THE PHYSICIAN STATED THE PUNCTURE WAS A HIGH STICK AND WAS NOT CAUSED BY THE ANGIO-SEAL DEVICE. THE ANGIO SEAL DEVICE INSTRUCTION FOR USE (IFU) INSTRUCTS THE USER NOT TO USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS PROXIMAL TO THE INGUINAL LIGAMENT AS THIS MAY RESULT IN A RETROPERITONEAL BLEED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT A SINGLE WALL PUNCTURE TECHNIQUE SHOULD BE USED. THE POSTERIOR WALL OF THE ARTERY SHOULD NOT BE PUNCTURED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES.

IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) A 6F ANGIO-SEAL EVOLUTION WAS DEPLOYED IN THE RIGHT FEMORAL ARTERIOTOMY. NOTHING UNUSUAL WAS NOTED AT THE TIME OF DEPLOYMENT. WHILE IN THE RECOVERY AREA, THE PT EXPERIENCED LIGHT-HEADEDNESS, DIZZINESS, AND BECAME HYPOTENSIVE. THE PT RECEIVED AN INCREASED INTRAVENOUS FLUID LOAD, THE INTEGRILIN WAS DISCONTINUED, AND A CT SCAN REVEALED A RETROPERITONEAL BLEEDING EVENT. THE PT RETURNED TO THE CATH LAB AND UNDERWENT AN ANGIOGRAM WITH ACCESS FROM A LEFT GROIN PUNCTURE. THE ANGIOGRAM OF THE RIGHT ILIAC AND GROIN AREA REVEALED NO BLEEDING SOURCE. MANUAL COMPRESSION WAS APPLIED TO THE LEFT GROIN PUNCTURE. THE PT RECOVERED IN THE CCU AREA AND WAS REPORTED TO BE STABLE AFTER EXPERIENCING A SECOND HYPOTENSIVE EPISODE. THE PT WAS CLOSELY MONITORED DURING RECOVERY. THE PHYSICIAN STATED THAT THE RIGHT GROIN PUNCTURE WAS A HIGH STICK AND NOT CAUSED BY THE ANGIO-SEAL BUT FROM AN ISSUE WITH THE ILIAC ARTERY. THERE IS NO ADDITIONAL INFO AVAILABLE.