During preparation for a thrombectomy procedure, it was noticed that a penumbra system jet 7 reperfusion catheter (jet7) was fractured at the hub upon removal from the penumbra system jet7 kit dispenser hoop.The damage to the jet7 was found prior to use and therefore, it was not used in the procedure.The procedure was completed using another penumbra system jet7 kit.
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Results: the jet7 was fractured approximately 1.0 cm from the hub, underneath the strain relief.Conclusions: evaluation of the returned jet7 confirmed a fracture beneath the strain relief.If the device is forcefully mishandled at extreme angles during removal from the packaging hoop, damage such as a fracture may occur.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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