BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 19570416 · Received June 19, 2024

    Report

    Report Number
    2029046-2024-02018
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 23, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 23-JUN-2024, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31252082L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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 IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION WITH A QDOT MICRO¿ CATHETER AND THE PATIENT EXPERIENCED NEUROLOGICAL IMPAIRMENT THAT REQUIRED PROLONGED HOSPITALIZATION. FIRST, IT WAS REPORTED THAT THE MEDICAL TEAM WAS UNABLE TO GET THE SOUND POINTS TO FLOAT. THEY SELECTED THE CONTOURS THAT HAD BEEN DRAWN IN THE POINT LIST AND ASSIGNED THEM TO FLOAT FROM THERE WITHOUT RESOLUTION. WHEN THE TEAM CLICKED ON THE FLOAT BUTTON FROM THE SOUND WINDOW, THEY WERE ABLE TO GET THE POINTS TO FLOAT. THE PROCEDURE CONTINUED. IT WAS ALSO REPORTED THAT WHEN THEY CLICKED ON SET LAT, THE CARTO 3 SYSTEM WOULD SET THE LAT, BUT THE ANNOTATION LINE WAS NOT DISPLAYED. THE TEAM HAD TO CLICK OFF THE POINT AND GO BACK TO THE POINT TO MOVE THE ANNOTATION LINE. THE PROCEDURE CONTINUED. IT WAS ALSO REPORTED THAT THE BUTTON WAS MISSING FOR THE BACKUP OF THE CARTO REPLAY DATA. THE MEDICAL TEAM BACKED IT UP ONCE AND WHEN IT WAS COMPLETED BACKING UP, THE ISSUE WAS RESOLVED. AS FAR AS PATIENT CONSEQUENCE, IT WAS REPORTED THAT THE PATIENT HAD NOT WOKEN UP FROM THE PROCEDURE YET. THERE WERE NO OTHER VISIBLE SYMPTOMS ON THE PATIENT. THE PATIENT HAD BEEN TAKEN FOR A CAT (COMPUTED TOMOGRAPHY) SCAN BUT THAT THE CAT SCAN WAS NEGATIVE. THE PATIENT WAS TAKEN TO ICU. AT THIS POINT THE PATIENT WAS INTUBATED AND NOT AWAKE. AFTERWARD, THE PATIENT WOKE UP OVERNIGHT. THEY WERE AWAKE AND ALERT WITH NO DEFICITS. THE MEDICAL TEAM REPORTED THAT THE PATIENT TOOK A LONGER TIME TO AWAKEN AND CONTINUED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640194 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31252082L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization CARTO 3 RMT SYSTEM| FARAPULSE GENERATOR| NGEN GENERATOR