Results: the 3maxc was fractured approximately 21.0 cm from the hub.Conclusions: evaluation of the returned device confirmed the 3maxc was fractured.This damage may have occurred due to forceful handling of the 3maxc 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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During preparation for a thrombectomy procedure, the hospital technologist noticed that a penumbra system 3max reperfusion catheter (3maxc) snapped in half upon pulling it out of the dispenser hoop.The damaged 3maxc was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new 3maxc.
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