BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QDOT MICRO, UNI, TC , D

    MDR report key: 17625080 · Received August 25, 2023

    Report

    Report Number
    2029046-2023-01905
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Report Date
    August 25, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835017045
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE IS UNKNOWN. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL INSPECTION WAS PERFORMED AND THE PEBAX COMPONENT WAS OBSERVED BROKEN WITH PARTS EXPOSED. THE ROOT CAUSE OF THE BROKEN PEBAX CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. HOWEVER, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE, BUT THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. 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. THIS REPORT IS BEING SUBMITTED LATE DUE TO A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE QDOT MICRO PRODUCTS. BIOSENSE WEBSTER¿S INVESTIGATION DETERMINED THAT UPON APPROVAL OF QDOT IN THE UNITED STATES ON NOVEMBER 23, 2022, THE ELECTRONIC COMPLAINTS SYSTEM WAS NOT UPDATED AND THEREFORE MEDICAL DEVICE REPORTS WERE NOT SUBMITTED IN A TIMELY MANNER. THROUGH BIOSENSE WEBSTER¿S INVESTIGATION, IT WAS DETERMINED THAT THIS WAS AN ISOLATED CASE. AN INTERNAL ACTION WAS OPENED TO ADDRESS THIS ISSUE.¿ MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A QDOT-MICRO, UNI-DIRECTIONAL, D CURVE, C3, SPLIT HANDLE CATHETER AND THE TIP OF THE CATHETER WAS BROKEN. THERE WERE NO LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. AN AGILIS SHEATH WAS USED DURING THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919176 QDOT MICRO, UNI, TC , D CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 30997829L 10846835017045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AGILIS SHEATH