BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15726652 · Received November 4, 2022

    Report

    Report Number
    2029046-2022-02723
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 7, 2022
    Report Date
    January 19, 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

    DEVICE INVESTIGATION DETAILS: ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, 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 30837246L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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. INITIAL REPORTER PHONE: (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 27-DEC-2022, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT DID NOT REQUIRED EXTENDED HOSPITAL STAY. THERE WAS NO OTHER RELEVANT MEDICAL HISTORY. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 66-YEAR-OLD MALE PATIENT, WEIGHING 75 KGS, UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CORONARY ARTERY STENOSIS REQUIRING A PERCUTANEOUS CORONARY INTERVENTION (PCI). IT WAS REPORTED CORONARY ARTERY STENOSIS OCCURRED IMMEDIATELY AFTER ABLATION. PCI WAS PERFORMED AND THE PROCEDURE WAS TERMINATED WHEN THE PATIENT'S CONDITION WAS RECOVERED. ALTHOUGH BLOOD PRESSURE TEMPORARILY DECREASED, THE PATIENT RECOVERED WITH MEDICATION AND PCI. THERE IS NO PARTICULAR PROBLEM NOW. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT: THE INDIRECT SPREAD OF HEAT AFTER THE ABLATION MAY BE A FACTOR RATHER THAN DIRECT DAMAGE DUE TO ABLATION. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION RECEIVED INDICATING THE PATIENT OUTCOME FROM THE ADVERSE EVENT IS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522358 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30837246L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention 7FR DECAN,11P,D,2.4MMLE,282MM,| JPN CARTO 3 SYSTEM| SOUNDSTAR ECO SMS 8F CATHETER| UNK_SMARTABLATE GENERATOR