BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16078235 · Received December 30, 2022

    Report

    Report Number
    2029046-2022-03261
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    December 5, 2022
    Report Date
    January 22, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3-JAN-2023, BWI RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON THE CARTO AND THE RECORDING SYSTEM. THE PHYSICIAN HAD ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM, ON THE ANESTHESIA MONITOR. DURING THE SIGNAL INTERFERENCE, THE AFFECTED CATHETER WAS INSIDE THE PATIENT¿S BODY. SINCE ECG SIGNAL WAS CONFIRMED AS AVAILABLE, THIS EVENT IS CLASSIFIED AS BAD/PARTIAL ECG. THIS EVENT IS NO LONGER CLASSIFIED AS A COMPLETE LACK OF BS OR ECG SIGNAL (WHICH IS WHAT WAS INITIALLY REPORTED). THE H6 MEDICAL DEVICE PROBLEM CODE "COMMUNICATION OR TRANSMISSION PROBLEM (A13)" NO LONGER APPLIES. THE CODE HAS BEEN UPDATED TO SIGNAL ARTIFACT (A090801). BAD/PARTIAL ECG IS NOT MDR-REPORTABLE. NO FURTHER REPORTS WILL BE SENT FOR THIS EVENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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. 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 UNKNOWN PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. IT WAS REPORTED THAT ALL EKG SIGNALS WERE NOISY. THE CATHETER CABLE WAS REPLACED, AND THE ISSUE DID NOT RESOLVE. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. BAD/NO ECG ACROSS ALL CHANNELS (BS AND IC) IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2825026 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30898115L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown