BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 14720168 · Received June 16, 2022

    Report

    Report Number
    2029046-2022-01344
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    May 20, 2022
    Report Date
    September 6, 2022
    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

    (B)(6). 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 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 INVESTIGATION WAS COMPLETED ON 06-SEP-2022. 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 30726717L 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: PC-(B)(4).

    Additional Manufacturer Narrative · 0

    INITIALLY THE LOT NUMBER WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 04-JUL-2022 PROVIDING THE LOT #. THEREFORE, PROCESSED D 4. LOT, D 4. EXPIRATION DATE AND H 4. DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 10-AUG-2022, THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS NOT RELATED WITH THE BIOSENSE WEBSTER INC. PRODUCT. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. RELEVANT DATA SHOWS AV1: 1 CONDUCTION AND THE BLOOD PRESSURE WAS STABLE BY TEMPORARY PACE AND LONG-DURATION VENTRICULAR TACHYCARDIA (EXACT DURATION IS UNKNOWN). THE GENERATOR USED WAS A SMARTABLATE (OUTPUT CONTROL, TEMPERATURE CUTOFF 40 ° C, RESISTANCE CUTOFF 250O, FLOW RATE PRE TIME 1S, POST TIME 5S). 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 AN 84-YEAR-OLD FEMALE PATIENT (40KG) UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED HEART BLOCK REQUIRING A TEMPORARY PACEMAKER. DURING AN ATRIAL FLUTTER ABLATION, ATRIOVENTRICULAR CONDUCTION RATIO DECREASED. ABLATION STATUS, OUTPUT CONTROL 25W, 7S, AI 240. AFL CEASED DUE TO SUBSEQUENT ABLATION, RESULTING IN SLOW HEART RATE (CL 1800MS), JUNCTIONAL RHYTHM, BLOOD PRESSURE 60S 80S SYSTOLIC. DUE TO PROLONGED ATRIAL TACHYCARDIA (AT), MODELING HAS PROGRESSED, AND CONDUCTION WAS POOR FROM THE BEGINNING. ABLATION WAS CONTINUED AT A PACE, AND CAVOTRICUSPID ISTHMUS (CTI) BLOCK WAS COMPLETED. A TEMPORARY PACEMAKER WAS IMPLANTED, AND THE PATIENT LEFT THE ROOM. THE PATIENT IS RECOVERING / RESOLVING. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THERE WAS NO IMPACT OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF THE BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS NOT RELATED WITH THE BIOSENSE WEBSTER, INC. PRODUCT. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153572 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30726717L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention UNK_SMARTABLATE GENERATOR.