BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER

    MDR report key: 10607650 · Received September 30, 2020

    Report

    Report Number
    2029046-2020-01357
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 8, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER WHERE DEBILITATING NOISE ON ALL ELECTROCARDIIOGRAM (ECG) CHANNELS OCCURRED. IT WAS REPORTED THAT DURING THE AF OPERATION, THE SIGNAL INTERFERENCE (NOISE/LOSS) WAS OBSERVED ON ALL INTRACARDIAC (IC) AND BODY SURFACE (BS) CHANNELS. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. DEVICE EVALUATION DETAILS: THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND IN GOOD CONDITIONS. THEN, ELECTRICAL TEST WAS PERFORMED, AND THE CATHETER FAILED, NO ELECTRICAL READINGS WERE OBSERVED ON ELECTRODE #02. A FAILURE ANALYSIS WAS PERFORMED, AND THE CATHETER WAS DISSECTED ON THE TIP AREA, THE ELECTRICAL WIRES WERE FOUND BROKEN FROM CUT TO PINS CAUSING THE IMPROPER ELECTRICAL SIGNAL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE ELECTRICAL WIRE BREAKAGE CANNOT BE DETERMINED. 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

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 · 1

    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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER WHERE DEBILITATING NOISE ON ALL ELECTROCARDIOGRAM (ECG) CHANNELS OCCURRED. IT WAS REPORTED THAT DURING THE AF OPERATION, THE SIGNAL INTERFERENCE (NOISE/LOSS) WAS OBSERVED ON ALL INTRACARDIAC (IC) AND BODY SURFACE (BS) CHANNELS. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THERE WAS NO RECORDING SYSTEM AVAILABLE--ONLY CARTO WAS USED. THERE WAS NO EXTERNAL SIGNAL SUCH AS DEFIBRILLATOR OR ANESTHESIA MONITOR AVAILABLE. DURING THE SIGNAL INTERFERENCE/LOSS, THE AFFECTED CATHETER WAS INSIDE THE PATIENT¿S BODY. THE DEBILITATING NOISE ON ALL ECG CHANNELS IS AN MDR-REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070874 THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LYB BIOSENSE WEBSTER INC 30345507M

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTO SYSTEM