BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DABRA

    MDR report key: 8354196 · Received February 20, 2019

    Report

    Report Number
    2032864-2019-00001
    Event Type
    Injury
    Date Received
    February 20, 2019
    Date of Event
    February 12, 2019
    Report Date
    February 20, 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

    A DISSECTION WAS OBSERVED IN THE LEFT SFA DURING THE PROCEDURE; THE DISSECTION WAS NOT TREATED EMERGENTLY, BUT IT WAS REPAIRED WITH A BALLOON. THE CASE WAS FINISHED WITH THE BALLOON, AS IT WOULD HAVE BEEN REGARDLESS OF THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147498 DABRA EXCIMER LASER CATHETER PDU RA MEDICAL SYSTEMS, INC. 101

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention