Results: the penumbra system ace 68 reperfusion catheter (ace68) was fractured just distal to the strain relief, approximately 3.5 cm from the hub.Conclusions: evaluation of the returned device confirmed it was fractured just distal to the strain relief.This damage may have occurred due to forceful handling of the ace68 at extreme angles during removal from the packaging hoop.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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