BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DABRA

    MDR report key: 8165469 · Received December 14, 2018

    Report

    Report Number
    2032864-2018-00001
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    October 12, 2018
    Report Date
    December 13, 2018
    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
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE WAS UNDERGOING A REVASCULARIZATION PROCEDURE OF A FOCAL LESION IN THE POSTERIOR TIBIAL ARTERY. THE PHYSICIAN USING THE DABRA CATHETER ENCOUNTERED RESISTANCE AT THE LESION, AND PERFORATED AT THE PT BRANCH. PHYSICIAN USED A BALLOON TO CLOSE THE PERFORATION. LESION WAS OPENED AND BLOOD FLOW WAS RESTORED. FINAL RESULT REPORTED AS ADEQUATE AND PATIENT WAS DISCHARGED WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004767 DABRA EXCIMER LASER CATHETER PDU RA MEDICAL SYSTEMS, INC. 101 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention