6F ANGIO-SEAL STS PLUS ST. JUDE MEDICAL

NO PRODUCT WAS RETURNED FOR EVAL AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. 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. THE ANGIO-SEAL PT INFO GUIDE STATES SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURES; HOWEVER, THE PT SHOULD CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THE PT INFO CARD IF THEY EXPERIENCE FEVER, BLEEDING, PERSISTENT SWELLING IN THE GROIN OR SWELLING, REDNESS AND/OR WARM TO TOUCH, NUMBNESS, TINGLING OR PAIN IN THE EXTREMITY WHEN AMBULATING, RASH, WOUND DRAINAGE OR ANY OTHER UNUSUAL SYMPTOMS.

IT WAS REPORTED THAT FOLLOWING A CORONARY ANGIOGRAM, A 6F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE IN THE RIGHT GROIN. EIGHT DAYS LATER, THE PT CAME BACK COMPLAINING OF PAIN AND HEMATOMA IN THE RIGHT SIDE. NINE DAYS LATER, THE PT'S LEFT GROIN WAS ACCESSED AND THE RIGHT LOWER EXTREMITY ANGIOGRAM WAS PERFORMED. THE PHYSICIAN CONSULTED THE SURGEON FOR SURGICAL REPAIR OF THE RIGHT COMMON FEMORAL ARTERY. THE PT HAS RECOVERED. NO ADD'L INFO IS AVAILABLE.