BEUDAMED
    FDA Adverse Event Death Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 18979292 · Received March 26, 2024

    Report

    Report Number
    2029046-2024-01025
    Event Type
    Death
    Date Received
    March 26, 2024
    Date of Event
    February 16, 2024
    Report Date
    March 26, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND HAD DIED WHILE AWAITING ASSISTED LIVING OR NURSING HOME PLACEMENT AFTER THE ABLATION. IN THE POST PROCEDURE UNIT, THE PATIENT'S BLOOD PRESSURE WAS NOTED TO HAVE DROPPED. AN ECHOCARDIOGRAM WAS DONE AND NO ACUTE CHANGES WERE NOTED ON THE ECHO. THE MEDICAL TEAM THOUGHT THAT THE BLOOD PRESSURE DROP MAY HAVE BEEN RELATED TO ANESTHESIA. THE PATIENT WAS TO BE DISCHARGED TO REHAB OR A SKILLED NURSING FACILITY, BUT WHILE WAITING FOR PLACEMENT THE PATIENT CODED AND DIED. NO ARRHYTHMIA NOTED ON PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILATORS (ICD). PHYSICIAN DOESN'T THINK IT WAS RELATED TO THE ABLATION AND WAS RELATED TO THE PATIENT'S ADVANCED AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435717 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L CARTO 3 SYSTEM S/N: (B)(6) .| DECANAV CATHETER.| NGEN SYSTEM.| SMALL OPTRELL D-F CURVE CATHETER.| SOUNDSTAR CATHETER.