BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 13538934 · Received February 15, 2022

    Report

    Report Number
    2029046-2022-00308
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    January 19, 2022
    Report Date
    April 7, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K133916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: MFR # 2029046-2022-00307 FOR PRODUCT CODE D6DR252RT (WEBSTER¿ ELECTROPHYSIOLOGY CATHETER).

    Additional Manufacturer Narrative · 0

    THE HARDWARE INVESTIGATION WAS COMPLETED ON 09-MAR-2022. IT WAS REPORTED THAT A MALE PATIENT, BORN ON (B)(6) 1948, UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND A CARTO® 3 SYSTEM AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND A MAP SHIFT (NO ERROR MESSAGE/NO PATIENT MOVEMENT/CARDIOVERSION) ISSUE OCCURRED. IT WAS REPORTED THAT THEY WERE DOING POST MAPPING AND CREATED A RE-MAP AND THE MAP SHIFTED. THERE WAS NO CARTO 3 SYSTEM INDICATION/ERROR CODE FOR THE MAP SHIFT. THE REPORTER NOTED THAT THE PHYSICIAN DID NOT THINK THIS HAD ANYTHING TO DO WITH THE PATIENT'S INJURY. THE MAP SHIFT WAS DISCOVERED DURING REMAP AND NO ERRORS WERE OBSERVED. THE CATHETER WAS OUT OF SHELL. THE ISSUE WAS SEEN POST CRYO MAPPING. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER MAP SHIFT WAS +/- 1CM. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT AND THE PATIENT DID NOT MOVE BEFORE DETECTING THE SHIFT. DEVICE EVALUATION DETAILS: THE ISSUE WAS INVESTIGATED AND WAS FOUND THAT THE REPORTED MAP SHIFT WAS CAUSED BY HIGH METAL VALUES DURING MAPPING. THIS DEFECT IS BEING HANDLED PER SW DEFECT MANAGEMENT PROCESS. THE BWI FIELD SERVICE ENGINEER (FSE) VISITED THE ACCOUNT AND FOUND THAT THE BACKPLANE CARD HAD BENT PINS ON THE MAP PORT. BACKPLANE CARD WAS REPLACED, AND ALL TESTS PASSED. SYSTEM IS UP AND READY FOR USE. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR ASSOCIATED WITH CARTO 3 SYSTEM # 11163 WAS REVIEWED. NO SIMILAR COMPLAINTS WERE FOUND. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE SYSTEM 11163, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. BASED ON THE MRE, THE H4. DEVICE MANUFACTURE DATE HAS BEEN UPDATED. REGARDING THE ISSUES WITH THE MAP SHIFT AND THE BACKPLANE CARD, INTERNAL CORRECTIVE ACTIONS HAVE BEEN OPENED TO INVESTIGATE THESE ISSUES. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(6) HAS TWO REPORTS: (1) MFR # 2029046-2022-00307 FOR PRODUCT CODE D6DR252RT (WEBSTER¿ ELECTROPHYSIOLOGY CATHETER). (2) MFR # 2029046-2022-00308 FOR PRODUCT CODE FG540000 (CARTO® 3 SYSTEM) (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, BORN ON (B)(6), UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND A CARTO® 3 SYSTEM AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND A MAP SHIFT (NO ERROR MESSAGE/NO PATIENT MOVEMENT/CARDIOVERSION) ISSUE OCCURRED. IT WAS REPORTED THAT THERE WAS A PATIENT INJURY, A PERFORATION. THE CALLER REPORTED THAT EARLIER IN THE CRYOABLATION CASE, A TRANSEPTAL SHEATH SLIPPED OUT OF THE LEFT ATRIUM AND A CATHETER WAS INSERTED THROUGH IT TO PROBE FOR THE TRANSEPTAL HOLE, AND THE CATHETER WAS SEATED BACK INTO THE LEFT ATRIUM. LATER IN THE CASE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE), A PERICARDIAL EFFUSION WAS CONFIRMED. THE PHYSICIAN'S OPINION WAS THAT THIS HAPPENED WHEN THEY WERE ATTEMPTING TO GET THE CATHETER BACK INTO THE LEFT ATRIUM. A PERICARDIOCENTESIS WAS PERFORMED AND 400CC OF BLOOD WAS REMOVED AND THE DRAIN WAS LEFT IN. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. A DAY AFTER THE PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. DURING THE PROCEDURE, TWO TRANSEPTAL PUNCTURES WERE PERFORMED WITH AN ABBOTT BRK XS NEEDLE. A CAVOTRICUSPID ISTHMUS (CTI) ABLATION WAS PERFORMED AFTER COMING OUT OF THE LEFT ATRIUM, BEFORE THE INJURY WAS NOTICED. THERE WAS NO EVIDENCE OF A STEAM POP. THERE WAS EVIDENCE OF VERY SMALL PRE-EFFUSION BEFORE THE CASE BEGAN. THE EVENT OCCURRED POST-CRYO AND POST-CRYO MAPPING. IT WAS ALSO REPORTED, RELATED TO THAT SAME CASE, THAT THEY WERE DOING POST MAPPING, AND CREATED A RE-MAP AND THE MAP SHIFTED. THERE WAS NO CARTO 3 SYSTEM INDICATION/ERROR CODE FOR THE MAP SHIFT. THE REPORTER NOTED THAT THE PHYSICIAN DIDN'T THINK THIS HAD ANYTHING TO DO WITH THE PATIENT'S INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 26-JAN-2022. IT WAS REPORTED THAT THE PHYSICIAN FELT THAT THE EFFUSION OCCURRED WHEN HE TRIED TO ¿PROBE THE TX SITE¿ WITH THE DIAGNOSTIC CATHETER. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS RECOVERED. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT AND WAS DISCHARGED THE NEXT DAY. A TRANSSEPTAL PUNCTURE WAS PERFORMED. THE EVENT OCCURRED POST-CRYO. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ERROR MESSAGES WERE OBSERVED ON THE BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. FORCE VISUALIZATION FEATURES USED: GRAPH, DASHBOARD, VISITAG WITH THE VISITAG MODULE PARAMETERS FOR STABILITY SET AT: RANGE, IMPEDANCE. NO ADDITIONAL FILTER WAS USED WITH THE VISITAG AND IMPEDANCE FOR COLOR OPTIONS WERE USED PROSPECTIVELY. THE MAP SHIFT WAS DISCOVERED DURING REMAP AND NO ERRORS WERE OBSERVED. THE CATHETER WAS OUT OF SHELL. THE ISSUE WAS SEEN POST CRYO MAPPING. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER MAP SHIFT WAS +/- 1CM. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT AND THE PATIENT DID NOT MOVE BEFORE DETECTING THE SHIFT SINCE THE EVENT (CARDIAC TAMPONADE) IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE. THE MAP SHIFT ISSUE WAS ASSESSED AS A MDR REPORTABLE PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4918 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC FG540000 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male DEF 6F,4P,D,SD,252,10RDL,92CM.| PENTARAY NAV ECO 7FR, D, 2-6-2.| REPROCESS ACUNAV 8F-90 GE.| SMARTABLATE GENERATOR KIT-US.| UNK ABBOTT BRK NEEDLE.| UNK_BIOSENSE WEBSTER EP CATHETERS.