BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DABRA

    MDR report key: 9239853 · Received October 25, 2019

    Report

    Report Number
    2032864-2019-00008
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    June 24, 2019
    Report Date
    October 25, 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

    WHILE TREATING A (B)(6) MALE, A PERFORATION WAS OBSERVED IN A CALCIFIED LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. INFLATION OF A 2.5 AND THEN A 3.0 BALLOON RESOLVED THE PERFORATION. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035903 DABRA EXCIMER LASER CATHETER PDU RA MEDICAL SYSTEMS, INC. DABRA 101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention