BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 22904411 · Received August 27, 2025

    Report

    Report Number
    2029046-2025-02875
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    June 6, 2025
    Report Date
    August 27, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 AND MAGNETIC TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM, AND IT WAS RECOGNIZED AND VISUALIZED CORRECTLY. NO MAGNETIC ISSUES OR ERRORS WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 31547703L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE REDDISH MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE MAGNETIC SENSOR ERROR AND VISUALIZATION ISSUES REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT SCRUB OR TWIST THE TIP ELECTRODE AS DAMAGE TO THE TIP ELECTRODE BOND MAY OCCUR AND LOOSEN THE TIP ELECTRODE, OR DAMAGE MAY ALSO OCCUR TO THE CONTACT FORCE SENSOR AND AFFECT MEASUREMENT ACCURACY. IN ADDITION, IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, VERIFY COMPATIBILITY BETWEEN THE SHEATH AND CATHETER, ADVANCE THE CATHETER THROUGH THE SHEATH PRIOR TO INSERTION. ANY SHEATH < 8.5 F IS CONTRAINDICATED. 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 AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. INITIALLY, IT WAS REPORTED THAT THE CATHETER HAD A MAGNETIC DISTORTION ERROR (ERROR# UNKNOWN), WHEN TRYING TO GO INTO ABLATION ON THE CAVOTRICUSPID ISTHMUS (CTI) LINE. THE CATHETER ¿FLEW OFF THE SCREEN¿, AS SOON AS ABLATION WAS STARTED. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE MAGNETIC DISTORTION AND VISUALIZATION ISSUES WERE 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, A REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX WERE OBSERVED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 30-JUL-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055888 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31547703L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_NGEN RF GENERATOR.