BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 9570666 · Received January 9, 2020

    Report

    Report Number
    2029046-2020-00042
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    November 28, 2019
    Report Date
    November 28, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB IDENTIFIED FOREIGN MATERIAL STUCK TO THE SIDE OF THE DOME. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE TEMPERATURE COULD NOT BE DISPLAYED. THE PROCEDURE WAS COMPLETED BY REPLACING THE CATHETER WITH ANOTHER CATHETER. THERE WAS NO PATIENT CONSEQUENCE. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED, AND IT WAS FOUND TO HAVE SOMETHING CLEAR STUCK TO THE SIDE OF THE DOME. THE RETURNED DEVICE WAS THEN EVALUATED FOR ELECTRICAL RESISTANCE AND THE THERMOCOUPLE TEST FAILED. FURTHER EXAMINATION REVEALED THAT THE THERMOCOUPLE WIRES WERE BROKEN AT THE TIP SECTION, CREATING AN INTERMITTENCE OF TEMPERATURE. DURING THIS TEST, THE DOME WAS INSERTED INTO A WATER CONTAINER AND THE MATERIAL WAS LOST, THIS COULD BE RELATED TO SALINE SOLUTION USED DURING THE PROCEDURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE WITH LOT NUMBER 30232572M, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED. THE TEMPERATURE ISSUE DOES NOT REPRESENT ANY PATIENT SAFETY IMPACT SINCE THE DEVICE IS UNABLE TO DELIVER RADIO FREQUENCY (RF) ENERGY TO ABLATE. THE ROOT CAUSE OF THE DRIED SALINE SOLUTION COULD BE RELATED TO THE USAGE OF THE DEVICE DURING THE PROCEDURE. MANUFACTURER'S REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER, INC. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB IDENTIFIED FOREIGN MATERIAL STUCK TO THE SIDE OF THE DOME. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE TEMPERATURE COULD NOT BE DISPLAYED. THE PROCEDURE WAS COMPLETED BY REPLACING THE CATHETER WITH ANOTHER CATHETER. THERE WAS NO PATIENT CONSEQUENCE. THE NO TEMPERATURE ISSUE WAS ASSESSED AS NOT REPORTABLE. THE NO TEMPERATURE READING WAS HIGHLY DETECTABLE AND WILL REQUIRE REPLACING THE CATHETER. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. ON DECEMBER 13, 2019, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION, AND IT WAS NOTED THAT UPON INITIAL VISUAL INSPECTION THERE WAS SOMETHING CLEAR STUCK TO THE SIDE OF THE DOME. THIS EVENT WAS ORIGINALLY CONSIDERED NOT MDR REPORTABLE, HOWEVER, BIOSENSE WEBSTER, INC. BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH ADDITIONAL ANALYSIS AND TESTING ON DECEMBER 13, 2019 AND HAVE REASSESSED THIS COMPLAINT AS REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS DECEMBER 13, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32383 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30232572M

    Patients

    Seq Age Sex Outcome Treatment
    1