BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKCAS

    MDR report key: 9145359 · Received October 2, 2019

    Report

    Report Number
    3003084417-2019-00001
    Event Type
    Death
    Date Received
    October 2, 2019
    Date of Event
    July 17, 2019
    Report Date
    October 2, 2019
    Manufacturer
    STEREOTAXIS INC
    Product Code
    DQX
    PMA / PMN Number
    K071029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, A VERY SICK (B)(6) MALE WAS UNDERGOING A NON-ISCHEMIC VT ABLATION PROCEDURE IN THE RIGHT VENTRICLE WITH NO OTHER OPTIONS FOR TREATMENT. THE PATIENT WAS NOT GIVEN HEPARIN PRIOR TO THE BEGINNING OF THE PROCEDURE AND NO TRANSSEPTAL PUNCTURE WAS DONE DUE TO THE PROCEDURE BEING DONE IN THE RIGHT VENTRICLE. DURING THE MAPPING PHASE OF THE PROCEDURE, IT WAS NOTICED THAT THE RF GENERATOR HAD INITIATED ABLATION ON ITS OWN. THIS APPEARS TO OCCUR AT 11:14 IN THE PROCEDURE LOG. TO SUMMARIZE, AT 11:14 THE GENERATOR TURNED ON FOR 2.4 SECONDS, OFF FOR 1.1 SECONDS, THEN BACK ON FOR 1.1 SECONDS. THE GENERATOR WAS TURNED OFF BY THE PHYSICIAN. IT WAS NOTICED THAT THE FOOT PEDAL WAS INADVERTENTLY LEFT IN THE ROOM AND REMAINED CONNECTED TO THE RF GENERATOR FROM THE PRIOR DAY ABLATIONS. THE FOOT PEDAL WAS DISCONNECTED AND THE PROCEDURE CONTINUED. THE ATTENDING PHYSICIAN DID NOT BELIEVE THIS CONTRIBUTED TO THE EVENT. THE BWI NAVISTAR RMT CATHETER WAS USED FOR THE PROCEDURE. THE ABLATION PORTION OF THE PROCEDURE WAS BEING PERFORMED BY A FELLOW UNDER DIRECTION SUPERVISION OF THE ATTENDING PHYSICIAN DURING THE ENTIRE TIME. THE ATTENDING PHYSICIAN WAS RIGHT NEXT TO THE FELLOW DURING THE ENTIRE PROCEDURE. WHILE DELIVERING 50W OF POWER IN THE RV, THE TECH ENTERED INTO THE CONTROL ROOM AND SAID THAT THEY HAD HEARD A POP. THE IMPEDANCE ABRUPTLY INCREASED. THE PATIENT'S CONDITION RAPIDLY DETERIORATED AND CPR WAS INITIATED. A PERICARDIOCENTESIS WAS PERFORMED AND AN UNKNOWN AMOUNT OF BLOOD WAS REMOVED. AFTER APPROXIMATELY 1 HOUR OF RESUSCITATION, THE PATIENT EXPIRED. PER THE LOCAL STEREOTAXIS REPRESENTATIVE, THERE WERE NO LOCK-UPS, OR ISSUES WITH THE STEREOTAXIS SYSTEM AT THE TIME OF THE EVENT. A REVIEW FROM ENGINEERING REVEALED THE FOLLOWING ANOMALY IDENTIFIED A CAS FAILURE AT THE ONSET OF THE PROCEDURE. THE ATTENDING PHYSICIAN DID NOT BELIEVE THIS CONTRIBUTED TO THE EVENT. THE PATIENT DID NOT HAVE AN AUTOPSY. THE PHYSICIAN OPINION IS THAT STEREOTAXIS DID NOT CONTRIBUTE TO THIS EVENT AND THAT IT WAS DUE TO THE PATIENTS COMORBIDITIES AND A PERFORATION RESULTING FROM A STEAM POP. SINCE THERE WAS NOT AN AUTOPSY PERFORMED, THIS COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938425 QUICKCAS CAS DQX STEREOTAXIS INC 001-001751-1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death QUICKCAS CARDIODRIVE STERILE COMPONENT