BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER, CONTINUOUS FLUSH

    MDR report key: 11822382 · Received May 13, 2021

    Report

    Report Number
    2134265-2021-06254
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    January 21, 2021
    Report Date
    May 13, 2021
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. ARTICLE RECEIVED DATE IS USED. ISKANDER, P. (2021). A CASE OF SUBCAPSULAR RENAL HEMATOMA STATUS POST CELIAC ARTERY THROMBECTOMY. INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS, 81, 105798. DOI:10.1016/J.IJSCR.2021.105798.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. A CASE REPORT DETAILED THE EVENTS OF A PATIENT WHO PRESENTED TO THE HOSPITAL WITH PERSISTENT LEFT-SIDED ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN AND PELVIS REVEALED SPLENOMEGALY, A SOFT TISSUE FILLING DEFECT IN THE LUMEN OF THE CELIAC ARTERY AND THROMBUS WAS NOTED TO EXTEND UP THE COMMON HEPATIC ARTERY AND SPLENIC ARTERY. AT THIS TIME, AN EKOSONIC ENDOVASCULAR SYSTEM (EKOS) CATHETER WAS INTRODUCED THROUGH THE LEFT ILIAC ARTERY AND POSITIONED IN THE PROXIMAL PORTION OF THE CELIAC TRUNK TO ASSIST IN A CATHETER ASSISTED THROMBOLYSIS. ALTEPLASE INFUSION WAS ALSO INITIATED AT 1 MG/HR AS WELL AS A HEPARIN INFUSION AT 500 UNITS/HR. THE PATIENT TOLERATED THE PROCEDURE WELL AND THE CATHETER WAS REMOVED AT BEDSIDE THE FOLLOWING DAY. PATIENT WAS DISCHARGED ON ASPIRIN AND APIXABAN FOR ANTICOAGULATION. THE NEXT DAY, PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SIGNIFICANT PAIN ASSOCIATED WITH SHORTNESS OF BREATH AND NAUSEA. A REPEAT CT SHOWED REDEMONSTRATIONS OF THE CELIAC THROMBUS AND SPLENOMEGALY. ADDITIONALLY, THE LEFT KIDNEY SHOWED EVIDENCE OF LEFT SUBSCAPULAR HEMATOMA. A LEFT SUPERFICIAL FEMORAL ARTERY PSEUDOANEURYSM WAS ALSO NOTED. ANTICOAGULATION WAS DISCONTINUED AND PATIENT WAS MADE NPO (NOTHING BY MOUTH). THREE DAYS LATER THE HEMATOMA HAD INCREASED. PATIENT WAS MONITORED FOR THREE MORE DAYS AND MANAGED CONSERVATIVELY WITH INTRAVENOUS FLUIDS AND PAIN MEDICATION. PATIENT REMAINED HEMODYNAMICALLY STABLE AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714887 CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention