Model Number 4FC12 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 02/19/2016 |
Event Type
Injury
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Manufacturer Narrative
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This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
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Event Description
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It was reported that post cryoablation procedure, coronary angiography showed cardiac tamponade.It was noted that the cause was unknown; however, the aspirated blood was venous blood.The patient remained under control at the coronary care unit.The blood in the pericardium was drained and the patient's condition was stable.The case had been completed with cryo.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the data files for the date of the reported event were returned and analyzed.The data files do not show any system notices or issues.No product was returned for investigation.No product malfunction was reported; a known clinical issue was encountered during the procedure.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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