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  • Complications and Failure Modes of the Penumbra Indigo CAT RX Aspiration System in Percutaneous Coronary Intervention: Insights From the MAUDE Database

    The Penumbra Indigo CAT RX aspiration system (Penumbra, Inc. Alameda, California, USA) is a mechanical thrombectomy device that is used to remove fresh thrombi from the coronary arteries in patients with acute myocardial infarction (AMI) [  ]. It consists of a low-profile CAT RX catheter (5.3 F) that is connected via aspiration tubing to the Penumbra ENGINE which can deliver and maintain a negative pressure of 29 in Hg, along with a separator wire which may be used to clear the lumen of the catheter should it become blocked with thrombus [  ]. It received FDA approval in May 2017 [  ]. However, data on mechanisms of failure are limited.

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