6F ANGIO-SEAL VIP ST. JUDE MEDICAL PUERTO RICO, B.V.

IT WAS REPORTED THAT A 6F ANGIO-SEAL WAS DEPLOYED. WITHIN A FEW SECONDS SWELLING WAS NOTED AT THE GROIN SITE AND THE COLLAGEN AND SUTURE POPPED THROUGH THE PUNCTURE HOLE WITH PULSATILE BLEEDING PRESENT. MANUAL COMPRESSION WAS APPLIED, THE PT WAS KEPT OVERNIGHT, AND THERE WERE NO PT CONSEQUENCES. UPON EXAMINATION LATER, THE PHYSICIAN STATED THE COLLAGEN AND SUTURE WERE SATURATED AND THAT THE SUTURE APPEARED TO BE UNRAVELED WITH NO ANCHOR PRESENT.

A FOLLOW UP MEDWATCH WILL BE SUBMITTED AT THE COMPLETION OF OUR INVESTIGATION.