BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 19684323 · Received July 5, 2024

    Report

    Report Number
    2029046-2024-02267
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    March 29, 2024
    Report Date
    July 5, 2024
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. THE RETURNED DEVICE'S VISUAL INSPECTION AND MAGNETIC SENSOR FUNCTIONALITY TESTS WERE PERFORMED FOLLOWING BIOSENSE WEBSTER (BWI) PROCEDURES. VISUAL ANALYSIS REVEALED A BREAKAGE ON THE SURFACE OF THE PEBAX AND INTERNAL PARTS EXPOSED. A MAGNETIC SENSOR FUNCTIONALITY TEST WAS PERFORMED, AND THE CATHETER WAS RECOGNIZED ON THE SYSTEM; HOWEVER, ERROR 106 WAS DISPLAYED ON THE SCREEN DUE TO AN OPEN CIRCUIT ON THE TIP AREA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31238187L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE MAGNETIC SENSOR ERROR REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) IN CARTO 3 SYSTEM CONTAIN THE FOLLOWING RECOMMENDATIONS: THE MAGNETIC SENSOR OF THE CATHETER BE DISCONNECTED. IF THE PROBLEM PERSISTS, REPLACE THE CATHETER CABLE OR THE CATHETER. THE ROOT CAUSE OF THE PEBAX DAMAGE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A BREAKAGE ON THE SURFACE OF THE PEBAX AND INTERNAL PARTS EXPOSED. INITIALLY, IT WAS REPORTED THAT AN ERROR (105) OCCURRED. IT WAS OBSERVED WHEN THE CATHETER WAS ADVANCED INTO THE CARDIAC CAVITY AND WAS OBSERVED DURING ZEROING. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER TO A NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE MAGNETIC SENSOR ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 12-JUN-2024, THE PEBAX WAS OBSERVED BROKEN. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 12-JUN-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447267 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31238187L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown