BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17597207 · Received August 22, 2023

    Report

    Report Number
    2029046-2023-01828
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 22, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE: (B)(6). THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31051090M 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE THAT INCLUDED THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE. TAMPONADE HAPPENED DURING CTI ABLATION WITH THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. ABLATION ON THE LEFT ATRIUM PERFORMED BEFORE. ADDITIONAL INFORMATION WAS RECEIVED. PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS BWI PRODUCT MALFUNCTION, PROCEDURE AND PATIENT CONDITION. INTERVENTION PROVIDED WAS REMOVAL OF THE PERICARDIAL FLUID AND BLOOD TRANSFUSION. OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED. TRANSSEPTAL PUNCTURE WAS PERFORMED, BRK XS SERIES, ST. JUDE MEDICAL, REF (B)(4), LOT 9000026. ABLATION WAS PERFORMED PRIOR TO NOTING CARDIAC TAMPONADE. NO EVIDENCE OF STEAM POP. EVENT OCCURRED AFTER THE TRANSSEPTAL PHASE, LEFT ATRIUM WAS ABLATED, THEN THE CATHETER WAS PULLED BACK TO THE RIGHT AND SHEATH WAS REMOVED FROM THE SEPTUM, DURING THE ABLATION IN THE RIGHT ATRIUM, THE TAMPONADE OCCURRED. WHICH IS IN OPINION OF THE PHYSICIAN WAS BECAUSE OF THE BLEEDING DUE TO TRANSSEPTAL PUNCTURE WHICH OCCURRED AFTER THE SHEATH WAS REMOVED. IRRIGATED CATHETER FLOW SETTINGS: HIGH FLOW (0-30 W) 17 ML/MIN, HIGH FLOW (30+ W) 30 ML/MIN, LOW FLOW 2 ML/MIN. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. PUMP SWITCHED FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. NO ERRORS ON BIOSENSE WEBSTER PRODUCTS. FORCE VISUALIZATION FEATURES USED: GRAPH, VECTOR, VISITAG. NO ADDITIONAL FILTER WAS USED WITH THE VISITAG. COLOR OPTIONS: FTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53595 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31051090M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R NGEN RF GENERATOR| PENTARAY NAV ECO 7FR, D, 2-6-2| ST. JUDE MEDICAL BRK XS TRANSSEPTAL NEEDLE| UNKNOWN BRAND PUMP| UNK_CARTO 3