Results: the penumbra system 3max reperfusion catheter (3maxc) was fractured approximately 29.0 cm from the hub.Conclusions: evaluation of the returned device revealed that 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 staff noticed that the penumbra system 3max reperfusion catheter (3maxc) was kinked upon removal from the packaging.The damaged 3maxc was found prior to use and therefore, the 3maxc was not used in the procedure.The procedure was completed using another 3maxc.
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