Description of Event or Problem · 1
CARTOXP RMT ELECTROANATOMIC MAPPING SYSTEM -BIOSENSE WEBSTER- DID NOT RECOGNIZE ABLATION CATHETER WHEN CONNECTED. PT WAS UNDER GENERAL ANESTHESIA, VENOUS ACCESS WAS OBTAINED, AND CATHETERS INSERTED INTO THE HEART. CATHETER ELECTROGRAMS AND SURFACE 12-LEAD EKG TRANSMITTED FROM CARTO TO EP MED RECORDING SYSTEM -ST. JUDE MEDICAL- AND CARTO SOFTWARE SCREEN DISPLAYED GREEN COM-UNIT LIGHTS, BUT COULD NOT REFERENCE THE CATHETER IN 3-D SPACE. GREEN LIGHTS ON CARTO SYSTEM BECAME INTERMITTENT, AND COMMUNICATION TESTING WAS PERFORMED. SYSTEM INTERMITTENTLY PASSED COMMUNICATION TESTING, BUT WOULD THEN FAIL. CARTO REP WAS ALREADY ON SITE FOR CLINICAL CASE SUPPORT. CALLED TECH SUPPORT LINE. VISUAL INSPECTION OF THE FIBEROPTIC -FO- CABLE CONNECTING CARTO COM-UNIT TO PT INTERFACE UNIT -PIU- APPEARED INTACT. REPLACEMENT CABLE WAS USED TO TROUBLESHOOT, AT WHICH POINT EXISTING FO CABLE WAS UNPLUGGED FROM CARTO PIU. PLASTIC FEMALE RECEPTACLE FOR FO CABLE CAME OFF FREELY FROM THE PIU WITH THE MALE FO CABLE PLUG AND COMMUNICATION WITH SYSTEM TERMINATED COMPLETELY. REPLACEMENT PIU REQUIRED PER CARTO FIELD SERVICE ENGINEER, WOULD HAVE TO BE SHIPPED. PROCEDURE ABORTED, PT EMERGED FROM ANESTHESIA AFTER RESOLUTION OF PARALYTIC AGENTS AND TRANSPORTED TO RECOVERY ROOM IN STABLE CONDITION. REPLACEMENT UNIT AND CABLES SENT WITH MODIFIED FO RECEPTACLE AND FO CABLE, AS THIS FRACTURE WITH PREVIOUS STYLE CONNECTION WAS A "KNOWN ISSUE" RESOLVED THROUGH NEW CONNECTION/NEW CABLE. DATES OF USE: (B) (6) 2009 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: ELECTROANATOMIC MAPPING.