BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 11408872 · Received March 4, 2021

    Report

    Report Number
    2029046-2021-00276
    Event Type
    Injury
    Date Received
    March 4, 2021
    Date of Event
    February 11, 2021
    Report Date
    February 11, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K133916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA AVRT/WOLFF-PARKINSON-WHITE (WPW)ABLATION. AN ERROR 1: NO COMMUNICATION WITH THE PATIENT INTERFACE UNIT (PIU) DETECTED, WAS PRESENT ON THE CARTO 3 SYSTEM 20 MINUTES INTO THE PROCEDURE. THIS RESULTED IN THE CANCELLATION OF THE CASE AFTER THE PATIENT WAS UNDER ANESTHESIA FOR APPROXIMATELY 2 HOURS. THE ERROR 1: NO COMMUNICATION WITH THE PIU DETECTED, WAS PRESENT ON THE CARTO 3 SYSTEM 20 MINUTES INTO THE PROCEDURE. TO TROUBLESHOOT THE PIU AND WORKSTATION WERE REBOOTED, THE FIBER OPTIC CABLE WAS RESEATED WHILE THE SYSTEM WAS OFF, WITHOUT RESOLUTION. THE FIBER OPTIC CABLE WAS EXCHANGED, AND SYSTEM REBOOTED AGAIN, AND IT WAS OPERATIONAL FOR 20 MORE MINUTES THEN THE ERROR 1 APPEARED AGAIN. THE ORIGINAL FIBER OPTIC CABLE WAS THEN CONNECTED AGAIN, AND SYSTEM REBOOTED, ERROR 1 PERSISTED. DURING THE REBOOT OF THE PIU THEY WAITED 3 MINUTES BEFORE BOOTING THE WORKSTATION BACK UP. THE TEAM WAS ADVISED TO RECONNECT WITHIN 15 SECONDS OF THE PIU AND STARTING A NEW STUDY. THE SYSTEM THEN INITIALIZED FULLY WITHOUT THE ERROR. THEN THEY WERE ADVISED TO USE THE SECOND (ETHERNET PORT 1 ON THE RIGHT) ON THE PIU AND REBOOTING. THIS WAS DONE, THE INITIAL STUDY CONTINUED. THE SAME ISSUE RECURRED, AND THE CASE WAS ABORTED AS A RESULT. SINCE THE EVENT IS LIFE-THREATENING AND REQUIRED INTERVENTION AND PROLONGED HOSPITALIZATION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306741 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC FG540000 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R