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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); No Known Impact Or Consequence To Patient (2692); Pericardial Effusion (3271)
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Event Date 01/29/2020 |
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 cryoablation procedure, a drop in blood pressure and effusion were noted.As a result of this the procedure was aborted with the patient under general anesthesia.Pericardiocentesis was performed, and blood was removed from the chest and returned to patient.The patient subsequently needed further surgery to repair the injury.Additionally, perforation may have also occurred.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Correction: a2, a3, d4, h4 if information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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