BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DABRA

    MDR report key: 8754673 · Received July 2, 2019

    Report

    Report Number
    2032864-2019-00004
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 2, 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 FEMALE WITH A 17.5 CM CALCIFIED OCCLUSION IN THE SFA/POPLITEAL/TP TRUNK. A FEMORAL CONTRALATERAL APPROACH WITH AN ANSEL GUIDING SHEATH AND A CORDIS VISTA BRITE STR WERE USED WITH THE DABRA. THE PHYSICIAN PLACED THE CATHETER THROUGH THE GUIDE CATHETER AND TRIED TO ADVANCE THEM AS A UNIT. DURING THE PROCEDURE, THE CATHETER KINKED AND SUBSEQUENTLY BEGAN TO CHAR THE INNER DIAMETER OF THE GUIDE CATHETER. THE DABRA AND GUIDE CATHETER WERE REMOVED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO INJURY TO THE PATIENT AND NO EMERGENT INTERVENTION NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550018 DABRA EXCIMER LASER CATHETER PDU RA MEDICAL SYSTEMS, INC. 101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other