BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVX® THROMBECTOMY SET

    MDR report key: 6829663 · Received August 30, 2017

    Report

    Report Number
    2134265-2017-08535
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    August 7, 2017
    Report Date
    August 8, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K133629
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PIECE OF THE DEVICE THAT BROKE OFF AND REMAINS INSIDE THE PATIENT'S BRAIN. AN AVX® THROMBECTOMY SET WAS SELECTED FOR A PROCEDURE IN THE LEFT SIDE OF THE BRAIN,. THE TIP BROKE OFF AND REMAINS IN THE PATIENT. THERE WERE NO FURTHER REPORTED COMPLICATIONS AND THE PATIENTS STATUS WAS FINE SO FAR POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610922 AVX® THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 105039-001 19047261

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other