Description of Event or Problem · 1
PT UNDERWENT A BILATERAL CAROTID AND VERTEBRAL ANGIOGRAM IN 2003. A RIGHT GROIN ANGIOGRAM WAS PERFORMED PRIOR TO USING THE CLOSER S 6 FR. DEVICE. IT WAS REPORTED THAT THE PT "QUALIFIED" FOR THE USE OF THE PERCLOSE CLOSURE DEVICE AND THE PUNCTURE SITE WAS CLOSED "ACCORDINGLY". 6 DAYS LATER, THE PT PRESENTED TO THE HOSP WITH COMPLAINTS OF AN "ACHING TYPE" OF PAIN IN THEIR RIGHT LEG WITH SOME NUMBNESS. THE PT STATED THAT THE PAIN WOULD BECOME "WORSE" WHEN WALKING AND DESCRIBED IT AS A "CHARLEY HORSE" TYPE OF CRAMPING PAIN IN THE RIGHT CALF. IT WAS REPORTED THAT THE PT'S RIGHT FEMORAL AND PEDAL PULSES WERE NOT PALPABLE BUT WERE PRESENT BY DOPPLER AND THE RIGHT FOOT WAS SLIGHTLY COOLER THAN THE LEFT. AN ANGIOGRAM OF THE RIGHT LEG CONFIRMED A RIGHT COMMON FEMORAL ARTERY OCCLUSION. A SURGICAL CONSULT WAS THEN OBTAINED AND THE SURGEON INFORMED THE PT THAT THEY "LIKELY" HAD A RIGHT COMMON FEMORAL ARTERY OCCLUSION SECONDARY TO THEIR RECENT CATHETERIZATION. THE FOLLOWING DAY, THE PT WAS TAKEN TO SURGERY FOR A RIGHT COMMON FEMORAL ARTERY ENDARTERECTOMY WITH A RIGHT GREATER SAPHENOUS VEIN PATCH ANGIOPLASTY. THE SURGEON REPORTED THAT "A LARGE AMOUNT OF FIBROTIC REACTION WAS NOTED AROUND THE COMMON FEMORAL ARTERY SECONDARY TO THE VASCULAR CLOSURE DEVICE". THE SURGEON ALSO REPORTED THAT THERE WAS THROMBOSIS OF THE ARTERY NOTED IN THE AREA OF THE CLOSURE DEVICE, A MODERATE AMOUNT OF INTIMAL DAMAGE AND A LARGE AMOUNT OF POSTERIOR PLAQUE. WHILE STILL IN SURGERY, JUST PRIOR TO DRESSING THE INCISION, THE PT WAS NOTED TO HAVE SOME ARTERIAL BLEEDING FROM THE WOUND. THE WOUND WAS REOPENED AND IT WAS DISCOVERED THAT A SMALL AREA OF THE VEIN PATCH ANGIOPLASTY WAS ACTIVELY BLEEDING. A SUTURE WAS PLACED AND THE BLEEDING STOPPED. THE WOUND WAS IRRIGATED WITH ANTIBIOTIC SALINE SOLUTION AND RECLOSED. IT WAS REPORTED THAT THE PT TOLERATED THE PROCEDUREE WELL AND HAD A PALPABLE DORSALIS PEDIS PULSE. THE PT WAS THEN TAKEN TO THE RECOVERY ROOM IN "STABLE" CONDITION. THE PT WAS DISCHARGED 4 DAYS LATER. THERE ARE NO REPORTS OF ANY ADVERSE PT SEQUELAE. UPON FURTHER QUERY WITH THE CUSTOMER THE FOLLOWING INFO WAS RECEIVED. THE PHYSICIAN FIRST ATTEMPTED ARTERIOTOMY CLOSURE WITH A PERCLOSE A-T (THE CLOSER AK) DEVICE. IT WAS REPORTED THAT A LINK BREAK OCCURRED. THE DEVICE WAS REWIRED AND A CLOSER S 6 FR. DEVICE WAS THEN USED AND SUCCESSFUL CLOSURE WAS ACHEIVED.