BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVX® THROMBECTOMY SET

    MDR report key: 5460336 · Received February 25, 2016

    Report

    Report Number
    2134265-2016-01034
    Event Type
    Injury
    Date Received
    February 25, 2016
    Date of Event
    January 30, 2016
    Report Date
    February 1, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K133629
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST PROCEDURE, THE PATIENT CODED. A AVX® THROMBECTOMY SET WAS SELECTED AND USED WITHOUT ANY ISSUE DURING THE PROCEDURE. HOWEVER, POST PROCEDURE THE PATIENT CODED AND WAS TREATED BY THE RAPID RESPONSE TEAM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118263 AVX® THROMBECTOMY SET CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 105039-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention