BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DABRA

    MDR report key: 9154049 · Received October 3, 2019

    Report

    Report Number
    2032864-2019-00007
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    August 5, 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) FEMALE WITH A 40 MM ATHEROMATOUS LESION IN THE SFA. A POPLITEAL RETROGRADE APPROACH WAS USED WITH THE DABRA CATHETER. THE PHYSICIAN EXPERIENCED ACCESS ISSUES; THE VESSEL WAS WIRED, THE SHEATH INSERTED, AND INTRAVASCULAR ULTRASOUND WAS USED. WHILE USING IVUS, THE PHYSICIAN PULLED THE SHEATH BACK TO SEE MORE OF THE POPLITEAL. WHEN HE TRIED TO INSERT THE DABRA CATHETER IT WOULD NOT ADVANCE BECAUSE THE SHEATH HAD BEEN PULLED BACK TOO FAR. ACCESS WAS GAINED A SECOND TIME; WHEN THE PHYSICIAN STARTED USING THE DABRA WITH A BUDDY WIRE TECHNIQUE, JUST AS IT EXITED THE SHEATH, IT WENT BEHIND OF PIECE OF PLAQUE AND PERFORATED THE SFA. THE PERFORATION WAS TREATED WITH BALLOON ANGIOPLASTY WITHOUT FURTHER COMPLICATION. THE PHYSICIAN STATED THAT THE PERFORATION WAS DUE TO THE VESSEL ACCESS AND THE PRESENTATION OF DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946837 DABRA EXCIMER LASER CATHETER PDU RA MEDICAL SYSTEMS, INC. 101

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention