Results: the penumbra system 3max reperfusion catheter (3maxc) was fractured approximately 58.0 cm from the hub, with visible yielding of the polymer distal and proximal to the fracture.Conclusions: evaluation of the returned device confirmed it was fractured.This damage may have occurred due to forceful handling of the 3maxc 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 noticed that the penumbra system 3max reperfusion catheter (3maxc) snapped in half as it was being removed from its packaging hoop.The 3maxc snapped in half prior to use and therefore, was not used in the procedure.The procedure was completed using a new 3maxc and a penumbra system ace 68 reperfusion catheter (ace68).
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