What's Happening?
Boston Scientific has updated the instructions for its Watchman heart device after reports of 120 serious injuries and 17 deaths. The FDA issued an early alert regarding the update, highlighting the risk of air bubbles entering the vascular system during implantation if the patient's breathing is not controlled. The update affects the FXD Curve, Truseal, and Trusteer access systems used in the procedure. The company advises physicians to manage risks by ensuring patients are not hypovolemic and by keeping the access valve below the heart during device exchange.
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Why It's Important?
The update is crucial for patient safety, as the Watchman device is widely used for left atrial appendage closure to prevent strokes in patients with atrial fibrillation. The changes aim to mitigate risks associated with the procedure, which could have significant implications for patient outcomes and healthcare practices. The incident highlights the importance of continuous monitoring and updating of medical device instructions to prevent adverse events and ensure patient safety.
