Results: the penumbra system 3max reperfusion catheter (3maxc) was fractured approximately 73.5 cm from the hub.Conclusions: evaluation of the returned device revealed that the 3maxc was fractured.This type of damage typically occurs due to improper handling during removal from the packaging.If the device is forcefully retracted at extreme angles out of the packaging hoop, damage such as a fracture may occur.Penumbra catheters are visually 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 a penumbra system 3max reperfusion catheter (3maxc) was snapped in half upon removal from 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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