BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 21600415 · Received March 13, 2025

    Report

    Report Number
    2029046-2025-00776
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    December 2, 2024
    Report Date
    March 13, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE THERMOCOOL SMARTTOUCH SF DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION AND MAGNETIC SENSOR FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED THE PEBAX WAS BROKEN WITH REDDISH MATERIAL. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM, AND IT WAS RECOGNIZED AND VISUALIZED CORRECTLY. NO ISSUES OR ERRORS WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31459988L NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE REDDISH MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE MAGNETIC ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTION FOR USE STATES: WHEN CLEANING THE TIP ELECTRODE, BE CAREFUL NOT TO TWIST THE TIP ELECTRODE WITH RESPECT TO THE CATHETER SHAFT; TWISTING MAY DAMAGE THE TIP ELECTRODE BOND AND LOOSEN THE TIP ELECTRODE, OR MAY DAMAGE THE CONTACT FORCE SENSOR. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, USE THE INSERTION TUBE SUPPLIED WITH THE CATHETER TO ADVANCE OR RETRACT THE CATHETER THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. AFTER INSERTION, SLIDE THE INSERTION TUBE BACK TOWARD THE HANDLE. AS PART OF J&J MEDTECH¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE WITH A NON-ISCHEMIC VENTRICULAR TACHYCARDIA (NON-ISVT)- LEFT FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A BROKEN PEBAX WITH REDDISH MATERIAL. INITIALLY, IT WAS REPORTED THAT A SENSOR ERROR (105) WAS DISPLAYED. IT WAS IMPOSSIBLE TO PERFORM THE ZERO-CONTACT FORCE. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE MAGNETIC SENSOR ERROR WAS ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION, THE PEBAX WAS FOUND BROKEN WITH REDDISH MATERIAL INSIDE. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 14-FEB-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992639 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31459988L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown