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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Anemia (1706); Chest Pain (1776); Dyspnea (1816); Hemorrhage/Bleeding (1888); Hemothorax (1896)
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Event Date 05/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: event date was not reported and was approximated to (b)(6) 2021.References: lal, a., jena, n., deepthi, t., kaur, j., apala, d., & patel, k.(2021, may 15).Rare complications from ekos in patients of massive pulmonary embolism.Cardiovascular team collaboration solving unique cases (pp.Volume 77, issue 18).Atlanta: jacc.
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Event Description
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Reported via journal article that patient experienced chest pain, dyspnea, blood loss anemia, bleeding in the pleura, hemomediastinum, hemothorax, hemopericardium, had bilateral chest tubes placed and pericardial window procedure.The patient was found unresponsive at his home.The patient had cardiac and respiratory arrest and cpr was performed for 30 seconds.Upon the emergency room arrival he was having sinus tachycardia.Heart rate was 150 and respirations were 25.The patient was hypoxic and placed on a non-rebreather.Ekg showed complete right bundle branch block but no ischemic changes.Troponin level was 0.90.The patient went for a ct angiogram which showed bilateral massive pulmonary emboli with right heart strain with "flattening of ivs and rv to lv ratio 1.9." the patient was treated with ekos pe catheters.A bolus of 2mg x 2 of tpa, followed by 1 mg/hr for 6 hours through each catheter was ordered.After ekos, patient started having chest pain, sob, and lethargy with blood loss anemia, and his hemoglobin dropped from 11 to 5.9.Chest x-ray showed a widened mediastinum.A chest ct showed hemomediastinum and hemothorax.An echocardiogram showed hemopericardium.Bilateral chest tubes were placed, which drained 2 litres.The pericardial window was done and drained serosanguinous fluid and the patient was kept in a cardiac unit for close monitoring.No further complications were reported.
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Search Alerts/Recalls
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