BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ER-REBOA¿ CATHETER

    MDR report key: 8144891 · Received December 8, 2018

    Report

    Report Number
    3012279212-2018-00009
    Event Type
    Injury
    Date Received
    December 8, 2018
    Report Date
    December 6, 2018
    Manufacturer
    PRYTIME MEDICAL DEVICES, INC.
    Product Code
    MJN
    PMA / PMN Number
    K172790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ER-REBOA CATHETER WAS USED ON A PATIENT FOR BALLOON OCCLUSION. THE OPERATING PHYSICIAN INDICATED BALLOON OCCLUSION WAS IN A "SMALL ARTERY, LEFT UP LONGER THAN NORMAL" AND THE PATIENT RECEIVED NOVOSEVEN (COAGULATION FACTOR VIIA). THE OPERATING PHYSICIAN DESCRIBED THE CLOTTING AS "NOT THE CATHETER'S FAULT BUT RELATED" AND "UNAVOIDABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984357 ER-REBOA¿ CATHETER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN PRYTIME MEDICAL DEVICES, INC. ER-REBOA 100010839

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention