BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO

    MDR report key: 25311490 · Received May 27, 2026

    Report

    Report Number
    2029046-2026-01703
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    February 25, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017052
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO QDOT MICRO CATHETER APPROVED UNDER P210027. THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL INSPECTION REVEALED THE PEBAX WAS DAMAGED. FURTHER INSPECTION UNDER MICROSCOPIC IMAGING REVEALED A HOLE IN THE PEBAX, WITH NO FOREIGN MATERIAL INSIDE. A FORCE TEST WAS PERFORMED AND THE DEVICE WAS RECOGNIZED AND VISUALIZED CORRECTLY; HOWEVER, THE FORCE VECTOR INVERTED AND HIGH FORCE READINGS APPEARED IN THE SYSTEM DUE TO INSUFFICIENT ADHESIVE APPLICATION ON THE WIRES INSIDE THE TIP. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31481428L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE FORCE SENSOR ERROR REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ROOT CAUSE ISSUE IS TRACED TO THE MANUFACTURING PROCESS. THE POTENTIAL CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. PEBAX DAMAGE IS UNRELATED TO THE ISSUE REPORTED BY THE CUSTOMER. THE CARTO® 3 SYSTEM INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: THE FORCE SENSOR OF THE CATHETER IS DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH JOHNSON & JOHNSON MEDTECH'S QUALITY SYSTEM. INTERNAL ACTIONS ARE BEING FOLLOWED TO REDUCE THIS FAILURE MODE. 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 ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. DURING THE PROCEDURE, A 106 ALERT CODE OCCURRED AFTER CATHETER PLUGGED INTO CARTO AND BEFORE FIRST ABLATION AS TIP THREADED THROUGH DISTAL END OF SHEATH (DISTAL EXIT). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. CATHETER WAS NOT USED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308772 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31481428L 10846835017052

    Patients

    Seq Age Sex Outcome Treatment
    1