BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15285519 · Received August 24, 2022

    Report

    Report Number
    2029046-2022-01969
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    July 28, 2022
    Report Date
    June 22, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). 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

    G1. MANUFACTURER SITE EMAIL AND G1. MANUFACTURER SITE PHONE WERE UPDATED WITH THE MOST RECENT CONTACT INFORMATION. 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 NUMBER 30754363L 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT (91KG) UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION (STSF) CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. CARDIAC TAMPONADE OCCURRED, TWO HOURS AFTER THE START OF THE PROCEDURE, DURING LEFT PULMONARY VEIN (LPV) CARINA ABLATION. THE CASE OF PVI WAS CONTINUED BECAUSE THE VITALS WERE STABILIZED AFTER THE PROCEDURE OF PERICARDIAL PUNCTURE AND DRAINAGE. THE PROCEDURE WAS TERMINATED IN FOUR HOURS. A PENTARAY WAS USED IN THE PROCEDURE. WHEN THE CATHETER WAS CONNECTED AT THE TIME OF MAPPING, ONE HOUR AFTER THE START OF THE CASE, 118 ERROR OCCURRED AND IT WAS NOT DISPLAYED. THE PROBLEM WAS NOT RESOLVED BY CHANGING THE CABLE. IT WAS RESOLVED WITH REPLACING THE CATHETER. THIS OCCURRED AT THE TIME OF ATRIAL SEPTOSTOMY, FORTY MINUTES AFTER THE START OF THE PROCEDURE. A SOUNDSTAR WAS USED IN THE PROCEDURE AND THE CATHETER DISPLAYED POOR IMAGING. IT DISPLAYED OR DISAPPEARED OFTEN. THE CABLE WAS REPLACED, AND THE SITUATION WAS NOT RESOLVED. IT WAS RESOLVED BY REPLACING THE CATHETER. DURING THE CASE, IT WAS CONFIRMED THAT THE HEART MOVEMENT WAS POOR AND BLOOD PRESSURE SLIGHTLY DECREASED. DRAINAGE WAS PERFORMED DURING SURGERY, AND THE CASE WAS STABILIZED. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ANY PROBLEM. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THERE WAS A TIME WHEN THE CONTACT FORCE (CF) INCREASED AT THE SAME TIME AS THE PATIENT WITH ¿SAS¿ HAD INCREASED RESPIRATION, AND AT THAT TIME, THE CATHETER MAY HAVE BEEN SLIGHTLY PERFORATED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PATIENT CONDITION AND PROCEDURE RELATED. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS RECOVERED. EXTENDED HOSPITAL STAY WAS NOT REPORTED. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. THE EVENT OCCURRED DURING ABLATION PHASE. ATRIAL SEPTAL PUNCTURE WAS PERFORMED WITH A RADIOFREQUENCY (RF) NEEDLE. STEAM POP WAS NOT CONFIRMED. FLOW RATE SETTING OF IRRIGATION CATHETER: = 30 W, 8 ML, = 31 W, 15 ML. THE SETTING WAS AS PER THE INSTRUCTION FOR USE (IFU). THE OUTPUT POWER WAS VARIED DEPENDING ON THE ABLATION POSITION. RANGE WAS 25 W TO 40 W. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THE PUMP WAS CORRECTLY CONTROLLED. FORCE VISUALIZATION FEATURES USED WERE DASHBOARD, VECTOR, VISITAG WITH THE VISITAG MODULE PARAMETERS FOR STABILITY SET AT 3MM3S, FOT; 3G/25%, TAG SIZE RADIUS 2MM. NO ADDITIONAL FILTER WAS USED. 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 DATA ERROR WAS ASSESSED AS NOT MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THE POOR OR NO ACOUSTIC IMAGING WAS ASSESSED AS NOT MDR REPORTABLE. IT IS EASILY DETECTABLE BY THE USER. THE PHYSICIAN WILL HAVE TO TROUBLESHOOT, AND THEN EXCHANGE THE CATHETER IN ORDER TO PROCEED WITH THE PROCEDURE, WHICH WOULD RESULT IN AN INTRA-PROCEDURAL DELAY. AN INTRA- PROCEDURAL DELAY WILL HAVE MINIMAL TO NO IMPACT ON PATIENT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019550 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30754363L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| R PENTARAY NAV ECO 7FR, D, 2-6-2.| PENTARAY NAV ECO 7FR, D, 2-6-2.| SMARTABLATE GEN. KIT (JAPAN).| SOUNDSTAR ECO SMS 8F CATHETER.| SOUNDSTAR ECO SMS 8F CATHETER.| UNK BRAND CABLE.| UNK BRAND CABLE.| UNK BRAND CATHETER.| UNK BRAND CATHETER.| UNK BRAND RADIOFREQUENCY (RF) NEEDLE.| UNK_CARTO 3.