BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC KIT 106CM 12CM TZ

    MDR report key: 13006818 · Received December 14, 2021

    Report

    Report Number
    2134265-2021-15510
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 19, 2021
    Report Date
    December 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K183361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # FIELD ON 3500A FORM: ADDITIONAL NUMBER K182324.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALARM ERROR OCCURRED. AN EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR THE TREATMENT OF PULMONARY EMBOLISM. FIVE HOURS AND SIX MINUTES INTO THE THERAPY, AN ALARM WAS RECEIVED INDICATING HIGH INSTANTANEOUS VOLTAGE SHUTOFF. TROUBLESHOOTING WAS PERFORMED BY CHECKING THE DEVICE FOR CROSS CONNECTIONS. THE CATHETERS WERE NOT CROSS CONNECTED. THE DEVICE WAS POWERED DOWN AND RESTARTED AFTER 20 SECONDS. HOWEVER, THE ALARM PERSISTED. THE CONNECTOR INTERFACE CABLE (CIC) ON THE DEVICE WAS SWITCHED FROM THE ALARMING CONTROL UNIT TO THE NON-ALARMING CONTROL UNIT. THE ALARM FOLLOWED TO THE NON-ALARMING CONTROL UNIT. THE ALARM WAS UNABLE TO BE RESOLVED THROUGH TROUBLESHOOTING SO THE CLINICAL SPECIALIST ADVISED THAT THE CONTROL UNIT GETS TURNED OFF. AT THE TIME OF REPORTING, IT IS UNKNOWN IF THE PATIENT RECEIVED ADEQUATE LYTIC DELIVERY AS DETERMINED BY THE PHYSICIAN. THE REPORT WILL BE UPDATED IF FURTHER INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897569 EKOSONIC KIT 106CM 12CM TZ CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown