BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9183105 · Received October 12, 2019

    Report

    Report Number
    2029046-2019-03751
    Event Type
    Injury
    Date Received
    October 12, 2019
    Date of Event
    September 17, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 11, 2019 AND IT WAS REPORTED THAT THE PATIENT WAS FEMALE, THEREFORE, SECTION A3. SEX WAS POPULATED WITH F. ALSO, THE PATIENT REQUIRED EXTENDED HOSPITALIZATION FOR OBSERVATION, THEREFORE, SECTION B 2. IS HOSPITALIZATION INITIAL/PROLONGED WAS SELECTED. IT WAS ALSO REPORTED THAT THE PERICARDIAL EFFUSION WAS NOTICED POST USE OF ANY BIOSENSE WEBSTER, INC. PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE RELATED. THE PATIENT¿S OUTCOME OF THE ADVERSE EVENT IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. EXTENDED HOSPITALIZATION WAS REQUIRED DUE TO PERICARDIAL EFFUSION AND THE PATIENT NEEDING A PERICARDIOCENTESIS. THE PATIENT WAS KEPT LONGER FOR OBSERVATION. IT IS UNKNOWN IF TRANSSEPTAL PUNCTURE WAS PERFORMED. ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION. THERE WAS NO EVIDENCE OF A STEAM POP. THE PERICARDIAL EFFUSION WAS NOTICED POST PROCEDURE, WHEN THE PATIENT WAS ABOUT TO BE TRANSPORTED TO THE RECOVERY BAY AND AFTER ALL CATHETERS WERE REMOVED FROM THE PATIENT¿S BODY. AN IRRIGATION CATHETER WAS USED, AND THE FLOW SETTINGS WERE SET AS PER THE INSTRUCTIONS FOR USE (IFU) FOR THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER: 15 ML FOR >31 W, 2 ML FOR LOW FLOW, AND 8 ML FOR <31 W. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. THE CATHETER WAS NOT ZEROED WHEN THE ISSUE OCCURRED. THE PHYSICIAN DOES NOT ZERO THE CATHETER UNTIL THE CATHETER IS IN THE LEFT ATRIUM (LA). THE PERICARDIAL EFFUSION WAS LIKELY CAUSED IN THE RIGHT ATRIUM (RA). THE CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. ON OCTOBER 17, 2019, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. UPON INITIAL VISUAL INSPECTION, IT WAS NOTED THAT THERE WAS NO VISUAL DAMAGE OR ANOMALIES OBSERVED. INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST PROCEDURE, THE PERICARDIAL EFFUSION WAS NOTICED AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 330 ML OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS MOVED TO THE INTENSIVE CARE UNIT (ICU). IT IS UNKNOWN IF ADDITIONAL HOSPITALIZATION WAS REQUIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT WAS LIKELY CAUSED BY THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER BEING ADVANCED TOO SUPERIORLY IN THE SUPERIOR VENA CAVA (SVC). IT WAS NOTED THAT ¿THE PHYSICIAN WAS OBSERVING THE X-RAY IMAGE ON THE SCREEN AND THOUGHT THE CATHETER WAS NOT CLOSE TO THE SEPTUM, SO HE ADVANCED THE CATHETER AND SCREENED ONLY TO REALIZE THAT IT WAS TOO SUPERIOR IN THE SUPERIOR VENA CAVA (SVC). HE REALIZED THE IMAGE HE LOOKED AT ORIGINALLY WAS A SAVED FLUOROSCOPY TAKEN PREVIOUSLY NOT A REAL TIME IMAGE. THERE WAS IN ISSUE WITH THE X-RAY MACHINE AT THE START OF THE CASE AND TOOK SEVERAL REBOOTS OF THE SYSTEM TO GET IT TO WORK. IT IS LIKELY THAT A SETTING WAS CHANGED WHICH CHANGED THE FLUOROSCOPY ACQUISITION SETTINGS.¿ THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND IN GOOD CONDITION. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THEN, THE FORCE SENSOR WAS TESTED, AND IT WAS WORKING PROPERLY, THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THEN, ELECTRICAL TESTING WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, THE CATHETER WAS TESTED ON THE GENERATOR AND THE TEMPERATURE AND IMPEDANCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THEN, THE IRRIGATION AND DEFLECTION TESTS WERE PERFORMED, AND THEY WERE FOUND WITHIN SPECIFICATION, THE CATHETER WAS IRRIGATING AND DEFLECTING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30230347L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST PROCEDURE, THE PERICARDIAL EFFUSION WAS NOTICED AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 330 ML OF FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS MOVED TO THE INTENSIVE CARE UNIT (ICU). IT IS UNKNOWN IF ADDITIONAL HOSPITALIZATION WAS REQUIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT WAS LIKELY CAUSED BY THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER BEING ADVANCED TOO SUPERIORLY IN THE SUPERIOR VENA CAVA (SVC). IT WAS NOTED THAT ¿THE PHYSICIAN WAS OBSERVING THE X-RAY IMAGE ON THE SCREEN AND THOUGHT THE CATHETER WAS NOT CLOSE TO THE SEPTUM, SO HE ADVANCED THE CATHETER AND SCREENED ONLY TO REALIZE THAT IT WAS TOO SUPERIOR IN THE SUPERIOR VENA CAVA (SVC). HE REALIZED THE IMAGE HE LOOKED AT ORIGINALLY WAS A SAVED FLUOROSCOPY TAKEN PREVIOUSLY NOT A REAL TIME IMAGE. THERE WAS IN ISSUE WITH THE X-RAY MACHINE AT THE START OF THE CASE AND TOOK SEVERAL REBOOTS OF THE SYSTEM TO GET IT TO WORK. IT IS LIKELY THAT A SETTING WAS CHANGED WHICH CHANGED THE FLUOROSCOPY ACQUISITION SETTINGS.¿ THE FORCE WAS NOT YET ZEROED AS THE CATHETER WAS NOT YET IN THE BLOOD POOL. IT IS UNKNOWN IF THE CATHETER WAS IN THE SHEATH AT THE TIME. ONLY THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND WEBSTER CS WITH AUTO ID CATHETER WERE USED. AN 8.5 FR AGILIS SHEATH WAS ALSO USED WITH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. APPROXIMATELY 7000 UNITS OF HEPARIN USED THROUGHOUT THE CASE TO KEEP THE ACT ABOVE 350. PROTAMINE WAS GIVEN POST CASE TO REVERSE THE HEPARIN. NO ERROR MESSAGES ON BIOSENSE WEBSTER, INC. EQUIPMENT WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977398 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30230347L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 8.5 FR AGILIS SHEATH| UNK_WEBSTER CS WITH AUTO ID