BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER

    MDR report key: 11898725 · Received May 27, 2021

    Report

    Report Number
    2029046-2021-00844
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    January 29, 2021
    Report Date
    January 29, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER, INC.(BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON 02/26/2021. THE DEVICE EVALUATION WAS COMPLETED ON 5/27/2021. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT A FOREIGN MATERIAL WAS OBSERVED ON THE THERMOCOOL SMARTTOUCH CATHETER. THE DEFLECTION MECHANISM WAS TESTED, AND IT FAILED. FURTHER INVESTIGATION REVEALED THE T BAR COMPONENT WAS SLID DOWN INSIDE THE TIP CAUSING THE IMPROPER DEFLECTION CONDITION. A FOURIER TRANSFORM INFRARED SPECTROSCOPY TEST (FTIR) WAS PERFORMED AND THE RESULTS SHOWED THAT WHITE PARTICLE IS PRIMARILY COMPOSED OF A POLYETHYLENE - BASED MATERIAL WITH A SECOND COMPONENT, BARIUM SULFATE THIS MATERIAL COMPOSITE IS WIDELY USED AS RADIO PACIFIER ALONG MEDICAL DEVICE INDUSTRIES. HOWEVER, SOURCE OF ORIGIN REMAINS UNKNOWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30453519M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AS PART OF BWI¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE ROOT CAUSE OF THE FOREIGN MATERIAL TRAPPED UNDER ELECTRODE CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB FOUND A FOREIGN MATERIAL TRAPPED UNDER AN ELECTRODE. INITIALLY, IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT ADVERSE EVENT WAS REPORTED. THE DEFLECTION ISSUE WAS NOT MDR REPORTABLE SINCE THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND ON 4/29/2021, A FOREIGN MATERIAL WAS FOUND TRAPPED UNDER ONE CATHETER ELECTRODE. THIS FINDING WAS ASSESSED AS MDR REPORTABLE, SINCE FOREIGN MATERIAL CAN CAUSE EMBOLISM OR STROKE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 4/29/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792707 THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30453519M

    Patients

    Seq Age Sex Outcome Treatment
    1