BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12030362 · Received June 20, 2021

    Report

    Report Number
    2029046-2021-00953
    Event Type
    Injury
    Date Received
    June 20, 2021
    Date of Event
    May 27, 2021
    Report Date
    January 6, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 1-NOV-2021, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. IT WAS REPORTED A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A TWO (2) THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DEVICE INVESTIGATION DETAILS: SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30515026M NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER:(B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, BWI RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: THE PHYSICIAN FELT THAT ON THE ONE HAND THERE WAS A PROBLEM WITH THE PRODUCT PRESSURE, ON THE OTHER HAND IT MIGHT BE RELATED TO HIS OWN OPERATION, THE PATIENT WAS SENT TO THE GENERAL WARD AFTER PERICARDIOCENTESIS AND RECOVERED WELL. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS FULLY RECOVERED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT: YES, OBSERVE WHETHER THERE IS EFFUSION AFTER PERICARDIOCENTESIS. A TRANSSEPTAL PUNCTURE PERFORMED WITH AN UNKNOWN NEEDLE. PRIOR TO NOTING THE CT ABLATION WAS PERFORMED. THE ABLATION STARTED MORE THAN 1 HOUR AFTER ISOLATION OF BOTH PULMONARY VEINS FROM THE MITRAL ISTHMUS LINE. IRRIGATED CATHETER WAS USED IN THE EVENT AND THE FLOW SETTING:- 25ML/MIN, THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION, HIGH FLOW. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. FORCE VISUALIZATION FEATURES USED: GRAPH, DASHBOARD, VECTOR AND VISITAG. THE VISITAG MODULE PARAMETERS FOR STABILITY WERE USED: - 2.5 MM, 3S, POINT 3. ADDED RESPIRATORY GATING AND COLOR OPTIONS USED PROSPECTIVELY: AVERAGE, FORCE, TIME, TEMPERATURE AND IMPEDANCE. ADDITIONALLY, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A TWO (2) THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. FORCE ISSUE & DEFLECTION ISSUE. PERICARDIAL TAMPONADE OCCURRED. DURING THE OPERATION OF PERSISTENT AF, THE FORCE WAS UNSTABLE AFTER THE CATHETER WAS ZEROED. THEN THE DEVICE WAS REPEATED DISPLAYED TO ZERO CORRECTION. THE HIGHEST FORCE REACHED 40-50 G. DURING THE PROCESS OF ABLATION, A STEAM POP OCCURRED TWICE (FORCE DID NOT CHANGE SIGNIFICANTLY DURING THE PERIOD OF POP). FORCE WAS STILL NOT STABLE ONE HOUR AFTER ABLATION. SWITCHED ANOTHER CATHETER TO ABLATE FOR 0.5H, PHYSICIAN FOUND THAT THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. PERICARDIAL TAMPONADE OCCURRED, OBSERVED SOME PERICARDIAL EFFUSION, BLOOD PRESSURE (80/50MMHG) AND OXYGEN SATURATION DECREASED, PERFORMED A PERICARDIAL PUNCTURE IMMEDIATELY, DRAINED PERICARDIAL EFFUSION. FIFTEEN MINUTES LATER, THE PATIENT WAS AWAKE. SURGEON CHANGED THE THIRD CATHETER, CONTINUED TO ABLATE FOR ABOUT 10 MINUTES, THEN COMPLETED THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE GENERAL WARD. PATIENT HAD NO PERICARDIAL EFFUSION TODAY AND WAS STABLE. STEAM POP IS NOT MDR-REPORTABLE. THE DEFLECTION ISSUE IS NOT MDR-REPORTABLE. THE FORCE ISSUE IS NOT MDR-REPORTABLE. SINCE THE CARDIAC TAMPONADE IS LIFE-THREATENING AND MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE OF A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE. THIS REPORT IS FOR THE SECOND OF 2 MDR-REPORTABLE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETERS. THE 1ST CATHETER WAS REPORTED UNDER MANUFACTURER REPORTER NUMBER 2029046-2021-00952.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926862 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LYB BIOSENSE WEBSTER INC 30515026M

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Life Threatening| H| R CARTO 3 SYSTEM.