Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
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Event Date 03/13/2019 |
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 a procedure, a cardiac effusion occurred following a transseptal puncture, and the patient became hypotensive.It was noted that the sheath had perforated.A pericardiocentesis was performed to stabilize the patient.It was noted that the inability to obtain a good septal view and the stiffness of the sheath may have contributed to the perforation.The outcome of this case 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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Additional information received indicated if procedures are aborted, the patient is always under general anesthesia.
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Search Alerts/Recalls
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