BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DABRA CATHETER

    MDR report key: 8493527 · Received April 8, 2019

    Report

    Report Number
    2032864-2019-00002
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 22, 2019
    Report Date
    April 8, 2019
    Manufacturer
    RA MEDICAL SYSTEMS, INC.
    Product Code
    PDU
    PMA / PMN Number
    170349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PREPARED FOR ENDOVASCULAR INTERVENTION IN THE L SFA. AT APPROXIMATELY 2 HOURS AFTER THE PATIENT WAS PUT ON THE TABLE, IN THE MIDDLE OF THE PROCEDURE, IT WAS FOUND THAT THE PATIENT WAS NOT HEPARINIZED. HEPARIN WAS ADMINISTERED AT THIS TIME. AFTER THE PROCEDURE WAS COMPLETE, THE PATIENT EXPERIENCED THROMBOSIS. THE PHYSICIAN BROUGHT THE PATIENT BACK ONTO THE TABLE AND PERFORMED ANOTHER INTERVENTION TO REMOVE THE THROMBOSIS. PATIENT RECOVERED WITH NO PERMANENT INJURY. THIS IS BEING REPORTED BECAUSE THE THROMBOSIS OCCURRED AFTER A DABRA PROCEDURE, ALTHOUGH THE CAUSE IS KNOWN NOT TO BE THE DABRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285257 DABRA CATHETER EXCIMER LASER CATHETER PDU RA MEDICAL SYSTEMS, INC. 101

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention