Results: the penumbra system ace 68 reperfusion catheter (ace68) was fractured approximately 105.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the ace68 was fractured.This damage may have occurred due to forceful handling of the ace68 at extreme angles during removal from the packaging.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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During preparation for a thrombectomy procedure, the hospital staff removed a penumbra system ace 68 reperfusion catheter (ace68) from the packaging of a penumbra system ace 68 high flow kit (kit) and went to straighten the ace68 out to flush it; however, the ace68 kept unraveling.The ace68 unraveled prior to use and therefore, was not used in the procedure.The procedure was completed using another kit.
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