BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 8077812 · Received November 16, 2018

    Report

    Report Number
    3001627457-2018-00033
    Event Type
    Death
    Date Received
    November 16, 2018
    Date of Event
    December 27, 2017
    Report Date
    November 2, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE CORRESPONDING AUTHOR THAT THE COMPLICATION (PULMONARY ARTERY PERFORATION RESULTING IN FATAL HEMOPTYSIS) WAS THOUGHT TO BE RELATED TO THE CHRONICALLY ELEVATED HEMIDIAPHRAGM. IT COULD NOT BE DETERMINED IF THE PA WAS PERFORATED BY THE GUIDEWIRE OR THE EKOS CATHETER. NO DEVICE MALFUNCTION WAS REPORTED. VESSEL PERFORATION AND HEMORRHAGE ARE KNOWN POTENTIAL COMPLICATIONS LISTED IN THE LABELING. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING CASE REPORT LITERATURE WAS REVIEWED ON 02 NOV 2018: TITLE: PULMONARY ARTERY RUPTURE AFTER ULTRASOUND-ASSISTED CATHETER-DIRECTED THROMBOLYSIS. AUTHORS: GUSTAVO FERNANDEZ ROMERO, BASHIR RIYAZ, ROHIT GUPTA, BRIAN O'MURCHU, VLADIMIR LAKHTER, CLAUDIA NIEVES PRADO, TALAL AKHTER, GARY COHEN, PARTH RALI. FACILITY: TEMPLE UNIVERSITY HOSPITAL, 3401 N BROAD ST PHILADELPHIA PA 19140. CORRESPONDING AUTHOR: GUSTAVO FERNANDEZ ROMERO, MD. EVENTS REPORTED: VESSEL PERFORATION RESULTING IN FATAL HEMOPTYSIS. A (B)(6) FEMALE WITH A HISTORY OF RECURRENT PULMONARY EMBOLI (PE), RECENT RETROPERITONEAL HEMATOMA (DUE TO ANTICOAGULATION) AND CHRONICALLY ELEVATED RIGHT HEMIDIAPHRAGM FOUND ON PRIOR IMAGING, PRESENTED WITH PROFOUND HYPOXIC RESPIRATORY FAILURE DUE TO ACUTE PE. PATIENT WAS NOTED TO HAVE BORDERLINE HYPOTENSION AND SEVERE RIGHT VENTRICULAR STRAIN. A MULTIDISCIPLINARY DECISION WAS MADE BY PE RESPONSE TEAM (PERT) TO PURSUE ULTRASOUND-ASSISTED CATHETER-DIRECTED THROMBOLYSIS (USCDT) WITH EKOS. THREE HOURS AFTER CATHETER PLACEMENT, MASSIVE HEMOPTYSIS OCCURRED REQUIRING INTUBATION. BEDSIDE BRONCHOSCOPY REVEALED BLEEDING FROM RIGHT LOWER LOBE (RLL). A BRONCHIAL BLOCKER WAS PLACED ON THE RIGHT SIDE AND THE PATIENT WAS TAKEN TO THE CATHETERIZATION LABORATORY FOR AN EMERGENT PULMONARY ANGIOGRAM. THE SOURCE OF BLEEDING WAS ANTERIOR BASAL SEGMENT OF THE RLL PULMONARY ARTERY (PA). THE BLEEDING WAS STOPPED BY DEPLOYING AN AMPLATZER VASCULAR PLUG (AVP) WITH RESOLUTION OF HEMOPTYSIS. UNFORTUNATELY, THE PATIENT DETERIORATED AND DIED. THE REPORTED INCIDENCE OF PA RUPTURE ASSOCIATED WITH THE USE OF A SWAN GANZ CATHETER IS 0.03-0.2%; HOWEVER, IT IS A SERIOUS COMPLICATION ASSOCIATED WITH HIGH MORTALITY. FOLLOWING A REQUEST FOR ADDITIONAL INFORMATION, THE CORRESPONDING AUTHOR REPORTED THAT THE CASE WAS PERFORMED ON (B)(6) 2017. THE EVENT WAS NOT REPORTED TO THE MANUFACTURER AT THE TIME OF THE EVENT SINCE THE COMPLICATION WAS THOUGHT TO BE RELATED TO THE CHRONICALLY ELEVATED HEMIDIAPHRAGM. IT COULD NOT BE DETERMINED IF THE PA WAS PERFORATED BY THE GUIDEWIRE OR BY THE EKOS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920989 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death