Model Number EP003994S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
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Event Date 01/17/2019 |
Event Type
Injury
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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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Event Description
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It was reported that during an radiofrequency procedure, hypotension occurred after the transeptal puncture.An echocardiogram confirmed a pericardial effusion was present.Pericardiocentesis was performed.The case outcome is unknown.No further patient complications have been reported as a result of this event.
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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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Event Description
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Incoming information indicated that the case was aborted.
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Search Alerts/Recalls
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