IT WAS REPORTED THAT DURING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE (AFIB), A PERFORATION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERFORATION WAS CONFIRMED BY ULTRASOUND. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 1050 ML OF FLUID WERE REMOVED. PROTAMINE WAS ADMINISTERED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS LATER REPORTED THAT THE DEVICE WAS IN THE RIGHT ATRIUM, AND A SOUND MAP HAD BEEN TAKEN WITH THE DEVICE. AN ABLATION CATHETER WAS USED TO GO TRANSSEPTAL AND MAPPING WAS STARTED WITH THE ABLATION CATHETER ALONG THE ROOF LINE OF THE LEFT ATRIUM. THERE APPEARED TO BE A LOT OF PRESSURE ON THE ABLATION CATHETER. IT WAS AT THIS POINT WHEN THE BLOOD PRESSURE DROPPED. THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT REQUIRED EXTENDED HOSPITALIZATION AND WAS DISCHARGED THE FOLLOWING DAY. THERE WERE NO REPORTED MALFUNCTIONS OF THE DEVICE DURING THE PROCEDURE. WE ARE TAKING A CONSERVATIVE APPROACH AND REPORTING THIS EVENT BECAUSE A STERILMED DEVICE WAS USED IN MAPPING.
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Patient 1
CONCOMITANT MEDICAL PRODUCTS: THE FOLLOWING BIOSENSE WEBSTER PRODUCTS WERE ALSO USED DURING THE PROCEDURE: CARTO 3 (14652), STOCKERT (S/N UNKNOWN) COOL FLOW PUMP (S/N UNKNOWN), SMARTTOUCH CATHETER (D133602, 17125402M), LASSO CATHETER (D7L1015CT, 17173874L), LASSO ECO CATHETER (D134301, 17150127L), LASSO ECO CATHETER (D134904, 17159560L), MOBICATH (D140010, W2891844), CS CATHETER (D610DRP10RT, 1704047M) THE DEVICE WAS RECEIVED BY THE MANUFACTURER AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE EVALUATION IS COMPLETE.
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Patient 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER COILED IN A PLASTIC BAG. FINAL DEVICE INVESTIGATION FOUND THAT THE RETURNED DEVICE HAD A KINK IN THE SHAFT. UPON EVALUATION, THE DEVICE PASSED ALL FUNCTIONAL TESTING, INCLUDING ALL MECHANICAL AND ELECTRICAL TESTING. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED.
Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)