BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 22290354 · Received June 19, 2025

    Report

    Report Number
    2029046-2025-01998
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Report Date
    June 18, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, TEMPERATURE AND IMPEDANCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED FOREIGN MATERIAL AT THE SURFACE OF THE DOME AREA. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM AND THE GENERATOR, AND NO TEMPERATURE WAS DISPLAYED. DUE TO THIS CONDITION, THE HANDLE OF THE DEVICE WAS DISSECTED AND RESISTANCE OF THE THERMOCOUPLES (TC) PADS ON THE CONNECTOR PRINTED CIRCUIT BOARD WAS MEASURED, AND AN OPEN CIRCUIT WAS IDENTIFIED ON THE TIP. THEN, A FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) WAS PERFORMED AND REVEALED THAT THE UNKNOWN MATERIAL SHOWS VIBRATIONS CORRESPONDENT TO METHACRYLATE-BASED MATERIAL, SLIGHT VARIATIONS SUGGEST MATERIAL MODIFICATIONS; HOWEVER. SOURCE OR ORIGIN AND CAUSE OR CHANGES REMAINS UNKNOWN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31491392L NUMBER, AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE TEMPERATURE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE OPEN CIRCUIT COULD NOT BE DETERMINED. THE FOREIGN MATERIAL WAS UNRELATED TO THE REPORTED EVENT. THE POTENTIAL CAUSE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONS: MONITOR THE CATHETER TIP TEMPERATURE RESPONSE THROUGHOUT THE PROCEDURE TO ENSURE ADEQUATE IRRIGATION. IF TEMPERATURE INCREASES VERY RAPIDLY DURING RF APPLICATION, POWER DELIVERY SHOULD BE INTERRUPTED. THE IRRIGATION SYSTEM MUST BE RECHECKED PRIOR TO RESTARTING RF APPLICATION. NOTE: THE DISPLAYED TEMPERATURE REPRESENTS THE TEMPERATURE OF THE ELECTRODE ONLY, NOT THE TEMPERATURE OF THE TISSUE. WHEN RF ENERGY IS INTERRUPTED FOR EITHER A TEMPERATURE OR AN IMPEDANCE RISE (THE SET LIMIT IS EXCEEDED), THE CATHETER SHOULD BE REMOVED, AND THE TIP SHOULD BE INSPECTED FOR CHAR/COAGULUM THAT MAY BE PRESENT ON THE TIP. IF PRESENT, DO NOT CONTINUE THE PROCEDURE WITH THE SAME CATHETER AND REPLACE THE CATHETER. IF NO CHAR/COAGULUM IS PRESENT, FLUSH THE TIP TO ENSURE THE IRRIGATION HOLES ARE NOT PLUGGED PRIOR TO REINSERTION OF THE CATHETER INSIDE THE PATIENT BODY. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. H 1. INITIAL REPORTER PHONE: (B)(6). 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 AN ATRIAL TACHYCARDIA (AT) CARDIAC PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A FOREIGN MATERIAL AT THE SURFACE ON THE DOME AREA. INITIALLY, IT WAS REPORTED THAT THERE WAS A TEMPERATURE SENSOR ERROR. ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE TEMPERATURE SENSOR ISSUE 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, THERE WAS A FOREIGN MATERIAL AT THE SURFACE ON THE DOME AREA. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 23-MAY-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864676 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31491392L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown