BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 24774339 · Received April 3, 2026

    Report

    Report Number
    2029046-2026-01065
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 27, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO. APPROXIMATELY ONE HOUR AFTER INSERTION INTO THE PATIENT'S BODY, WHEN ABLATION WAS STARTED, THE CATHETER TEMPERATURE ROSE, AND THE SET POWER OUTPUT COULD NOT BE SUPPLIED UNDER TEMPERATURE CONTROL. WHEN FLUSHING WAS PERFORMED OUTSIDE THE PATIENT'S BODY, THE SALINE SOLUTION FLOW WAS POOR. DEVICE INVESTIGATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. VISUAL INSPECTION, MICROSCOPIC EXAMINATION, TEMPERATURE, IMPEDANCE AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE TEMPERATURE AND IMPEDANCE TEST WAS PERFORMED, AND THE TEMPERATURE SUDDENLY INCREASED UNTIL THE CUTOFF VALUE WAS REACHED. THEN, AN IRRIGATION TEST WAS PERFORMED, AND THE CATHETER FAILED THE TEST, AS THERE WAS NO FLOW IN THE IRRIGATION HOLE. AFTERWARDS, AN ALUMINUM WIRE WAS INTRODUCED IN THE LUER HUB, AND THE WIRE GOT STUCK IN THE MIDDLE OF SHEATH. FINALLY, THE SHAFT WAS DISSECTED, AND THE IRRIGATION TUBE WAS INSPECTED, AND IT WAS FOUND OCCLUDED WITH DRY REDDISH MATERIAL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE DRY REDDISH MATERIAL OBSERVED INSIDE THE IRRIGATION TUBE COULD BE RELATED TO THE IRRIGATION AND TEMPERATURE ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE OCCLUSION CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING WARNINGS AND PRECAUTIONS: A COMPATIBLE IRRIGATION PUMP IS RECOMMENDED TO ENSURE PROPER IRRIGATION FLOW RATE. BEFORE USE, VERIFY THAT THE IRRIGATION PORTS ARE PATENT BY INFUSING HEPARINIZED NORMAL SALINE THROUGH THE CATHETER AND THE IRRIGATION TUBING. PURGE THE CATHETER AND THE IRRIGATION TUBING WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION OF THE CATHETER INTO THE PATIENT. INSPECT THE IRRIGATION SALINE FOR AIR BUBBLES PRIOR TO ITS USE IN THE PROCEDURE. AIR BUBBLES IN THE IRRIGATION SALINE MAY CAUSE EMBOLI. ALWAYS MAINTAIN A CONSTANT HEPARINIZED NORMAL SALINE INFUSION TO PREVENT COAGULATION WITHIN THE LUMEN OF THE CATHETER. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO. APPROXIMATELY ONE HOUR AFTER INSERTION INTO THE PATIENT'S BODY, WHEN ABLATION WAS STARTED, THE CATHETER TEMPERATURE ROSE, AND THE SET POWER OUTPUT COULD NOT BE SUPPLIED UNDER TEMPERATURE CONTROL. WHEN FLUSHING WAS PERFORMED OUTSIDE THE PATIENT'S BODY, THE SALINE SOLUTION FLOW WAS POOR. THE CATHETER WAS REPLACED TO HANDLE THE ISSUE. ¿CLOTS ATTACHMENT¿ WAS NOT OBSERVED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION INDICATED THAT THE CUTOFF VALUE WAS NOT EXCEEDED. THE ABLATION NEVER CONTINUED BEYOND THE CUT-OFF VALUE. THE GENERATOR ABLATION MODE WAS SET TO TEMPERATURE CONTROL MODE. TEMPERATURE CUT OFF: 45, IMPEDANCE CUT OFF: 250O. NO ERROR WAS NOTED FROM THE IRRIGATION PUMP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124627 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31766003L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown