BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO

    MDR report key: 23335331 · Received October 20, 2025

    Report

    Report Number
    MW5177525
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Report Date
    September 22, 2025
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARDIAC TAMPONADE/CARDIAC PERFORATION/PERICARDIAL EFFUSION OCCURRED. CARTO RF USED DURING REDO PVI (NOT FARAPULSE SYSTEM). STEAM POP OCCURRED AT THE EUSTACHIAN RIDGE DURING CTI ABLATION WITH RESULTANT PERICARDIAL EFFUSION REQUIRING URGENT PERICARDIOCENTESIS PERFORMED WITH 610 ML OF VENOUS BLOOD AUTO TRANSFUSED. LATER LIMITED TTE ON (B)(6) 2025 SHOWED NO PERICARDIAL EFFUSION. THIS REPORT REFLECTS INFO RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 11/6/2025 FOR REPORT MW5177525 TO UPDATE MANUFACTURER TO BIOSENSE WEBSTER, INC. AND PROCODE TO DQK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299045 CARTO COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER CARTO RF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown