BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18534791 · Received January 18, 2024

    Report

    Report Number
    2029046-2024-00208
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    December 20, 2023
    Report Date
    January 17, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    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 31156462L 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 A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND PATIENT EXPERIENCED A TRANSIENT ST SEGMENT ELEVATION TREATED WITH CAG AND NITROGLYCERIN. NOISE OCCURRED ON ALL ELECTRODES OF SPINE A OF THE OCTARAY CATHETER (D160901 / LOT: 31479099L) IN INTRACARDIAC ONLY, IN BOTH CARTO 3 AND LAB. TIMING OCCURRED AFTER CONNECTION AND INSERTION INTO THE PATIENT'S BODY. THE CATHETER WAS INSIDE THE PATIENT'S BODY AT THE TIME OF THE NOISE. RECONNECTION, CABLE REPLACEMENT, AND CATHETER REPLACEMENT RESOLVED THE PROBLEM. IN ADDITION, CAG WAS PERFORMED AFTER LOWER WALL INDUCTION AND V3 AND V4 ECG ST ELEVATION THAT DID NOT GO DOWN EASILY. MIGHT BE A SPASM. ST RETURNED AFTERWARDS, SO ABLATION WAS CONTINUED. NO ABNORMALITIES OBSERVED PRIOR TO USE OF THE PRODUCT OR DURING USE OF THE PRODUCT. THE PHYSICIAN¿S ASSESSMENT OF THE HEALTH PROBLEM WAS NON SERIOUS (MODERATE/MINOR). THE PHYSICIAN¿S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THE OCTARAY NOISE ISSUE WAS UNRELATED TO THE SYMPTOM. THERE WAS NO THROMBUS AND THE ABLATION WAS NOT PERFORMED ON THE PART THAT MIGHT BE RELATED TO THE SYMPTOM. IT MIGHT BE SPASM. ADDITIONAL INFORMATION WAS RECEIVED. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. ST-SEGMENT ELEVATION WAS FOUND A FEW HOURS AFTER THE OCTARAY CATHETER NOISE TROUBLE OCCURRED. INTERVENTION PROVIDED WAS CAG WAS PERFORMED AND NITROGLYCERIN WAS ADMINISTERED. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED. NO EXTENDED HOSPITALIZATION. SYMPTOM APPEARED TO HAVE BEEN TRANSIENT AND THE PATIENT WAS RECOVERED/STABLE WHEN LEAVING THE CATHETER ROOM. THE NOISE ISSUE WAS ASSESSED AS NOT REPORTABLE. THE RISK TO THE PATIENT WAS LOW. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817856 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31156462L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other 7FR,DEF,20MM DIA., CCW,LASSO| 8.5F SHEATH WITH CURVE VIZ SMC| OCTA,STD,48P,2-2-2-2-2,D-CURVE| OCTA,STD,48P,2-2-2-2-2,D-CURVE| SMARTABLATE GEN. KIT (JAPAN)| SOUNDSTAR ECO SMS 8F CATHETER| UNK RECORDING SYSTEM| UNKNOWN CABLE| UNK_CARTO 3