(b)(4).Results: the penumbra system ace 68 reperfusion catheter (ace 68) was kinked approximately 3.5 cm from the hub, fractured approximately 56.0 cm from the hub and ovalized approximately 120.0 cm from the hub.Conclusions: evaluation of the returned device revealed it was fractured.This damage likely occurred due to forceful retraction of the ace 68 through an rhv that was not sufficiently opened.Further evaluation revealed the ace 68 was kinked in the proximal shaft and ovalized in the distal shaft.These damages may have occurred due to forceful handling or manipulation of the ace 68 during use.The non-penumbra stent retriever and rhv mentioned in the complaint were not returned for evaluation.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system ace 68 hi-flow kit (kit).During the procedure, while following protocol, the physician removed the other manufacturer's stent retriever and then attempted to remove the penumbra system ace 68 reperfusion catheter (ace 68).While retracting the ace 68, the physician did not mention experiencing any resistance; however, the ace 68 became stuck in the rotating hemostasis valve (rhv) and began to stretch then separate.The physician believed that the rhv was too tight.Therefore, the rhv was loosened and the ace 68 was able to be removed intact.The procedure was then completed using a new ace 68.There was no report of an adverse effect to the patient.
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