BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15362771 · Received September 6, 2022

    Report

    Report Number
    2029046-2022-02120
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 8, 2022
    Report Date
    October 12, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS COMPLETED ON 21-SEP-2022. IT WAS REPORTED THAT A 70-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND AN EVALUATION OF ALL FEATURES OF THE DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE SHAFT OF THE DEVICE WAS BENT. PER THE EVENT, SEVERAL TESTS WERE PERFORMED. THE MAGNETIC, ELECTRICAL, TEMPERATURE AND FORCE FEATURES WERE TESTED, AND NO ISSUES WERE OBSERVED. IN ADDITION, THE PRODUCT WAS DEFLECTING CORRECTLY AND NO BLOCKAGES IN THE IRRIGATION CONDUCTS WERE FOUND. HOWEVER, DURING THE COOL FLOW PUMP TEST, HIGH PRESSURE VALUES WERE OBSERVED DUE TO THE IRRIGATION TUBE BEING BENT IN THE SHAFT AREA. IT WAS DETERMINED THAT THE DAMAGE OF THE SHAFT AND IRRIGATION TUBE MAY BE RELATED TO IMPROPER HANDLING OF THE DEVICE OUTSIDE THE BWI MANUFACTURING FACILITIES. NO OTHER MALFUNCTIONS WERE OBSERVED DURING THE PRODUCT ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30808004L, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN, SOME ISSUES REGARDING THE PRODUCT WERE FOUND DURING THIS INVESTIGATION BUT BASED ON THE EVENT INFORMATION THEY WERE UNRELATED TO THE EVENT DESCRIBED. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 70-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. THE PATIENT SUFFERED A CARDIAC TAMPONADE AFTER DOING SOME ABLATIONS AROUND THE LEFT SUPERIOR PULMONARY VEIN, THE PATIENT¿S PRESSURE DROPPED. THE INTRACARDIAC ECHO (ICE) CATHETER WAS USED TO CONFIRM A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND 650CC'S OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS STABLE AT THE TIME OF THE CALL AND BEING HELD OVERNIGHT FOR OBSERVATION WITH THE DRAIN IN PLACE. THE PHYSICIAN DID NOT STATE WHAT MAY HAVE BEEN THE CAUSE. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PATIENT FULLY RECOVERED. THE PATIENT WAS KEPT OVERNIGHT AND DISCHARGED THE NEXT DAY. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BAYLIS NEEDLE. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF A STEAM POP. THE EVENT OCCURRED DURING ABLATION PHASE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. FORCE VISUALIZATION FEATURES USED WERE GRAPH, DASHBOARD, VECTOR/ VISITAGS WITH THE VISITAG MODULE PARAMETERS FOR STABILITY WERE USED WAS 10. NO ADDITIONAL FILTER WAS USED WITH THE VISITAG. COLOR OPTIONS USED PROSPECTIVELY WERE IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243073 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30808004L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Life Threatening| R UNK BAYLIS NEEDLE| UNK GENERATOR| UNK_CARTO 3