Model Number 2AF284 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Hematoma (1884); Hemorrhage/Bleeding (1888); Necrosis (1971); Cardiac Tamponade (2226); Pericardial Effusion (3271)
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Event Date 12/15/2016 |
Event Type
Death
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that post cryo ablation procedure, the patient had experienced chest discomfort and a cardiopulmonary arrest.It was noted that the patient had left the operating room conscious and in good condition.An echocardiogram was performed and a pericardial effusion was observed.Drainage and intubation were performed.The patient was placed under monitoring in the intensive care unit (icu) and died three days later.An autopsy was performed and a cause of death could not be confirmed.However, discoloration due to a hematoma was observed in the left inferior pulmonary vein (lipv) and the right inferior pulmonary vein (ripv).Also, there was blood in the patient's abdomen and necrosis due to intestinal ischemia was observed.It was "inferred" that organ dysfunction due to cardiac tamponade had occurred contributing to the cause of death.The physician reported that there was a possibility that ablated tissue had gradually bled and "it was unknown if the cause of death was due to the heart".
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Manufacturer Narrative
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Product analysis: data files were returned and analyzed.Data files showed temperature spikes with the catheter.Also, data files showed that at least 21 injections were performed with the catheter without issue on the date of the event.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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