BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15627227 · Received October 18, 2022

    Report

    Report Number
    2029046-2022-02565
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    January 1, 2016
    Report Date
    October 17, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: THE CATALOG FOR THIS IS UNK_SMART TOUCH BIDIRECTIONAL SF. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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. 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 DATABASE RELATED RESEARCH ACTIVITY (DRRA) WAS RECEIVED FROM COTTAGE HEALTH RESEARCH INSTITUTE FOR BETWEEN JANUARY 2017 AND DECEMBER 2018. THERE WERE 3 AF RECURRENCES DURING A 12-MONTH FOLLOW UP PERIOD IN PATIENTS WITH AF UNDERGOING ABLATION USING STSF CATHETER. ADDITIONALLY, ONE PATIENT REQUIRED PERMANENT PACEMAKER FOR SYMPTOMATIC JUNCTIONAL RHYTHM AFTER SUCCESSFUL TERMINATION OF AF. SYMPTOMS RESOLVED AND THE PATIENT WAS DISCHARGED THREE DAYS AFTER THE ABLATION PROCEDURE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICES POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH® SF CATHETER ADVERSE EVENT(S) REPORTED FOR THERMOCOOL SMARTTOUCH® SF CATHETER FOR CARDIAC ABLATION PROCEDURES: QTY 3 AF RECURRENCES DURING 12 MONTH FOLLOW UP. ADDITIONALLY, ONE PATIENT REQUIRED PERMANENT PACEMAKER FOR SYMPTOMATIC JUNCTIONAL RHYTHM AFTER SUCCESSFUL TERMINATION OF AF. SYMPTOMS RESOLVED AND THE PATIENT WAS DISCHARGED THREE DAYS AFTER THE ABLATION PROCEDURE. SINCE THE EVENT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341842 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L