Vascular surgeon approached by bard to bring in this product to use.The bard reps were in the room.Recently approved to be used in us by fda.The patient was undergoing angiographic atherectomy using the rotarex device when the helix and burr disarticulated from the catheter device.The helix was prolapsed into the aorta and attempt at endosalvage was performed with a snare.This was attempted to be removed from the left groin, however, it was completely stuck within the calcium of the right lower extremity.Conversion to open extraction was performed for the right groin, however, the patient had significant drop in blood pressure and was concerned of intra-abdominal injury.Crash laparotomy was performed with aortic cross clamping.Fda safety report id# (b)(4).
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