BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATHETER, CONTINUOUS FLUSH

    MDR report key: 10683000 · Received October 15, 2020

    Report

    Report Number
    2134265-2020-14172
    Event Type
    Death
    Date Received
    October 15, 2020
    Date of Event
    April 9, 2020
    Report Date
    November 24, 2020
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6: PATIENT CODE. GRAIF, ASSAF, ET AL. EVALUATION OF FIBRINOGEN LEVELS DURING CATHETER-DIRECTED THROMBOLYSIS FOR ACUTE PULMONARY EMBOLISM. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, VOL. 31, NO. 8, 2020, PP. 1281-1289., DOI:10.1016/J.JVIR.2020.04.032. DATE OF DEATH AND EVENT DATE ARE UNKNOWN; THEREFORE, THEY ARE ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. A RETROSPECTIVE REVIEW WAS PERFORMED TO EVALUATE THE EFFECT OF CATHETER-DIRECTED THROMBOLYSIS WITH TISSUE PLASMINOGEN ACTIVATOR (TPA) ON PLASMA FIBRINOGEN LEVELS IN PATIENTS WITH ACUTE PULMONARY EMBOLISM. THE EKOSONIC ENDOVASCULAR SYSTEM CATHETER WAS A DEVICE REFERENCED WITHIN THE STUDY. MAJOR BLEEDING, CARDIAC ARREST, THROMBOCYTOPENIA, AND PROCEDURE RELATED DEATH WERE NOTED TO HAVE OCCURRED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    GRAIF, ASSAF, ET AL. EVALUATION OF FIBRINOGEN LEVELS DURING CATHETER-DIRECTED THROMBOLYSIS FOR ACUTE PULMONARY EMBOLISM. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, VOL. 31, NO. 8, 2020, PP. 1281-1289., DOI:10.1016/J.JVIR.2020.04.032. DATE OF DEATH AND EVENT DATE ARE UNKNOWN; THEREFORE, THEY ARE ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. A RETROSPECTIVE REVIEW WAS PERFORMED TO EVALUATE THE EFFECT OF CATHETER-DIRECTED THROMBOLYSIS WITH TISSUE PLASMINOGEN ACTIVATOR (TPA) ON PLASMA FIBRINOGEN LEVELS IN PATIENTS WITH ACUTE PULMONARY EMBOLISM. THE EKOSONIC ENDOVASCULAR SYSTEM CATHETER WAS A DEVICE REFERENCED WITHIN THE STUDY. MAJOR BLEEDING, CARDIAC ARREST, THROMBOCYTOPENIA, AND PROCEDURE RELATED DEATH WERE NOTED TO HAVE OCCURRED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149326 CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R