BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOJET SOLENT OMNI

    MDR report key: 13764700 · Received March 14, 2022

    Report

    Report Number
    2134265-2022-02588
    Event Type
    Death
    Date Received
    March 14, 2022
    Date of Event
    February 18, 2022
    Report Date
    March 14, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON ILIAC ARTERY. AN ANGIOJET SOLENT OMNI CATHETER WAS USED TO SUCCESSFULLY COMPLETE A THROMBECTOMY PROCEDURE. HOWEVER, A FEW HOURS AFTER THE PROCEDURE, A CT SCAN SHOWED A POTENTIAL EMBOLIZED RENAL. THE PHYSICIAN ATTEMPTED TO INTERVENE BUT WAS UNSUCCESSFUL. THE PATIENT PASSED AWAY DUE TO COMPLICATIONS WHILE TRYING TO TREAT POSSIBLE RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821845 ANGIOJET SOLENT OMNI CATHETER, EMBOLECTOMY KRA BOSTON SCIENTIFIC CORPORATION