IT WAS REPORTED THAT FIFTEEN MINUTES AFTER A TRANSSEPTAL PUNCTURE DURING AN A-FIB PROCEDURE, THE ANESTHESIOLOGIST NOTED A DROP IN THE PT'S BLOOD PRESSURE. AN INTRACARDIAC ECHO WAS USED TO VISUALIZE THE FLUID IN THE PERICARDIUM. A 700CC PERICARDIOCENTESIS OF FLUID REMOVAL FROM THE PERICARDIAL SPACE HAD TO BE PERFORMED. THE CUSTOMER WAS NOT SURE IF THE PERFORATION OCCURRED DURING THE TRANSSEPTAL STEP OR DURING ABLATION (THIS WAS THE FIRST ABLATION). THE PT WAS STABILIZED AND TRANSFERRED TO ICU. THE PT HAD FULLY RECOVERED. THE PROGNOSIS WAS EXCELLENT.
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Patient 1
INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. (SEE SCANNED PAGE).