6F ANGIO-SEAL VIP ST. JUDE MEDICAL, INC.

NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO REC'D, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE PUNCTURE SITE WAS STATED TO BE IN THE SUPERFICIAL FEMORAL ARTERY. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) ALSO INSTRUCT THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE THE FEMORAL ARTERY CHARACTERISTICS PRIOR TO PLACING THE ANGIO-SEAL DEVICE BY INJECTING CONTRAST MEDIUM THROUGH THE PROCEDURE SHEATH AND USING FLUOROSCOPY. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT IF THE PUNCTURE SITE IS AT OR DISTAL TO THE BIFURCATION OF THE SUPERFICIAL FEMORAL AND PROFUNDA FEMORIS ARTERY, AS THIS MAY RESULT IN THE ANGIO-SEAL DEVICE ANCHOR CATCHING ON THE BIFURCATION OR BEING POSITIONED INCORRECTLY, AND/OR COLLAGEN DEPOSITION IN THE VESSEL. THESE EVENTS MAY REDUCE BLOOD FLOW THROUGH THE VESSEL LEADING TO SYMPTOMS OF DISTAL ARTERIAL INSUFFICIENCY. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

IT WAS REPORTED FOLLOWING A PERCUTANEOUS PROCEDURE, A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM WAS NOT PERFORMED; HOWEVER, THE DEPLOYMENT TECHNIQUE WAS FOLLOWED IN THE INSTRUCTIONS FOR USE AS THE ANGIO-SEAL WAS DEPLOYED. HEMOSTASIS WAS ACHIEVED. THE PT EXPERIENCED VESSEL OCCLUSION AT THE PUNCTURE SITE AND LATER THAT EVENING UNDERWENT SURGICAL INTERVENTION. THE ANGIO-SEAL WAS REMOVED FROM THE SUPERFICIAL FEMORAL ARTERY AND THE PT'S CONDITION WAS REPORTED TO BE OKAY. THERE WAS NO ADD'L INFO AVAILABLE.