BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 21962181 · Received May 5, 2025

    Report

    Report Number
    2029046-2025-01433
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 4, 2025
    Report Date
    June 6, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ON 15-MAY-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND BEFORE THE PACKAGE WAS OPENED THE MEDICAL TEAM NOTICED FOREIGN MATERIAL BY THE HANDLE INSIDE THE PACKAGE. THE COLOR IS THE SAME BLUE COLOR AS THE HANDLE OF THE QDOT MICRO CATHETER. IT WAS APPROXIMATELY 1MM X 2MM. IT WAS INSIDE THE STERILE PACKAGING CLOSE TO THE HANDLE. IT BECAME LOOSE WHEN THE PACKAGE WAS OPENED. THE CATHETER WAS NEVER INSERTED IN THE BODY AS THE RT (RESPIRATORY THERAPIST) NOTICED THE FRAGMENT WHEN OPENING THE STERILE PACKAGING. THE CATHETER WAS REPLACED AND THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED IN ACCORDANCE WITH J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE PACKAGING OF THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A PICTURE SENT BY THE CUSTOMER SHOWING THE FOREIGN MATERIAL WAS EVALUATED; HOWEVER, IT DOES NOT PROVIDE ANY ADDITIONAL INSIGHT OF THE ISSUE, THE FOREIGN MATERIAL WAS NOT RETURNED FOR ANALYSIS; FURTHER INVESTIGATION COULD NOT BE PERFORMED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED BASED ON THE PICTURE. THE POTENTIAL CAUSE OF THIS ISSUE COULD NOT BE ESTABLISHED CONCLUSIVELY. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING RECOMMENDATION: THE STERILE PACKAGING AND CATHETER SHOULD BE INSPECTED PRIOR TO USE. DO NOT USE IF THE PACKAGING OR CATHETER APPEARS DAMAGED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31543099L, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH 'S 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 A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND BEFORE THE PACKAGE WAS OPENED THE MEDICAL TEAM NOTICED FOREIGN MATERIAL BY THE HANDLE INSIDE THE PACKAGE. THE COLOR IS THE SAME BLUE COLOR AS THE HANDLE OF THE QDOT MICRO CATHETER. IT WAS APPROXIMATELY 1MM X 2MM. IT WAS INSIDE THE STERILE PACKAGING CLOSE TO THE HANDLE. IT BECAME LOOSE WHEN THE PACKAGE WAS OPENED. THE CATHETER WAS NEVER INSERTED IN THE BODY AS THE RT (RESPIRATORY THERAPIST) NOTICED THE FRAGMENT WHEN OPENING THE STERILE PACKAGING. THE CATHETER WAS REPLACED AND THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475618 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31543099L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_NGEN RF GENERATOR