IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THIS REPORT IS FOR THE SECOND DEVICE USED ON THE PATIENT; SEE MDR 3013394970-2020-00167 FOR THE FIRST DEVICE REPORTED ON THE SAME PATIENT.
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Patient 1
THE USER FACILITY REPORTED THAT THE ANGIO-SEAL LOCATOR/INSERTION SHEATH ASSEMBLY WAS ATTEMPTED TO BE INSERTED INTO THE PUNCTURE SITE, BUT THE ASSEMBLY WAS NOT INSERTED BECAUSE THE TIP OF THE ASSEMBLY WAS KINKED. THE DEVICE WAS REPLACED WITH ANOTHER ANGIO-SEAL DEVICE TO CONTINUE THE PROCEDURE, BUT THE LOCATOR/INSERTION SHEATH ASSEMBLY WAS KINKED AT THE SAME PART AND COULD NOT BE INSERTED. THE SECOND DEVICE WAS REPLACED WITH A COMPETITOR'S DEVICE, WHICH WAS ABLE TO BE INSERTED INTO THE PUNCTURE SITE WITHOUT PROBLEM. SUBSEQUENTLY, HEMOSTASIS WAS SUCCESSFULLY ACHIEVED BY THE THIRD DEVICE. ANGIOGRAPHY REVEALED THAT THERE WAS NO CALCIFICATION, AND THE PHYSICIAN USED THE DEVICES PROPERLY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE PROCEDURE BEFORE DEPLOYING THE DEVICE WAS CAROTID ARTERY STENTING (CAS). A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE SIZE OF THE SHEATH ANCILLARY USED WAS 8 FR. IT IS UNKNOWN WHETHER THE PUNCTURE SITE WAS DISTAL OR PROXIMAL TO THE INGUINAL LIGAMENT OF THE RIGHT COMMON FEMORAL ARTERY. THE VESSEL DIAMETER IS UNKNOWN. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.