BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 21944966 · Received May 1, 2025

    Report

    Report Number
    2029046-2025-01401
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 1, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, IRRIGATION AND TEMPERATURE AND IMPEDANCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED REDDISH MATERIAL INSIDE THE PEBAX SLEEVE, DUE THIS CONDITION THE DEVICE WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND A HOLE ON THE PEBAX SURFACE. THEN, THE DEVICE WAS CONNECTED TO THE GENERATOR AND AN ABLATION CYCLE WAS PERFORMED AND THE DEVICE WAS FOUND WORKING CORRECTLY. NO TEMPERATURE OR IMPEDANCE ISSUES WERE OBSERVED. AN IRRIGATION TEST WAS PERFORMED, AND THE DEVICE WAS FLUSHING CORRECTLY, NO OBSTRUCTED HOLES WERE OBSERVED. NO IRRIGATION ISSUES WERE OBSERVED. THE REDDISH MATERIAL INSIDE THE PEBAX COULD BE RELATED TO THE TEMPERATURE ISSUE 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 COULD NOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 31416904L, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) STATES: 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. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE QUALITY SYSTEM. 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 THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE OCCLUSION PROCEDURE ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE PEBAX. DURING THE PROCEDURE, THERE WAS A TEMPERATURE SLOPE TOO HIGH MESSAGE AND THAT ABLATION STOPPED MESSAGE DISPLAYED ON THE NGEN. THE NGEN TO PATIENT INTERFACE UNIT (PIU) CABLE WAS REPLACED AND THE ISSUE PERSISTED. THE MEDICAL TEAM CHECKED THE IRRIGATION PORTS AND THE ISSUE PERSISTED. THE TEAM RESEATED THE CATHETER AND THE ISSUE PERSISTED. WHEN THE CATHETER AND CABLE WAS REPLACED, THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071924 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31416904L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN GENERATOR