BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DABRA

    MDR report key: 9154034 · Received October 3, 2019

    Report

    Report Number
    2032864-2019-00006
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    June 4, 2019
    Report Date
    October 3, 2019
    Manufacturer
    RA MEDICAL SYSTEMS, INC.
    Product Code
    PDU
    PMA / PMN Number
    K170349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN WAS TREATING A (B)(6)-YEAR OLD MALE WITH A 15 MM CALCIFIED LESION IN THE LEFT SFA. A FEMORAL ANTEGRADE APPROACH WAS USED WITH THE DABRA CATHETER. THE CATHETER WAS INTRODUCED INTO THE LSFA, AND AFTER ABOUT 5 CM OF TRAVEL, THE PATIENT COMPLAINED OF PAIN. THE LASER WAS STOPPED AND SUBSEQUENT ANGIO SHOWED A PERFORATION IN THE LSFA. THE PERFORATION WAS TREATED WITH BALLOON ANGIOPLASTY WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946723 DABRA EXCIMER LASER CATHETER PDU RA MEDICAL SYSTEMS, INC. DABRA 101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention