BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DABRA

    MDR report key: 8680860 · Received June 7, 2019

    Report

    Report Number
    2032864-2019-00003
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 7, 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 AN (B)(6) FEMALE WITH A 10 MM CALCIFIED OCCLUSION IN THE SFA. A FEMORAL CONTRALATERAL APPROACH WITH A FLEXOR GUIDING SHEATH AND A BARD SIDEKICK ANGLED GUIDE WERE USED WITH THE DABRA. IT WAS FOUND THAT THE LESION DID NOT ORIGINATE IN THE SFA AND COULD NOT BE VISUALIZED. THE PHYSICIAN PROCEEDED BLINDLY IN AN ATTEMPT TO REACH THE SFA. THE DABRA LASED FOR 2 SECONDS, THEN CROSSED INTO THE COMMON FEMORAL VEIN, RESULTING IN A FISTULA IN THE CFA/CFV. THE FISTULA WAS THEN BALLOONED FOR 3 MINUTES TO STOP THE FLOW. THE FISTULA WAS RESOLVED. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473105 DABRA EXCIMER LASER CATHETER PDU RA MEDICAL SYSTEMS, INC. 101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention