BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSSIS ANGIOJET LF 140 CATHETER

    MDR report key: 196017 · Received November 6, 1998

    Report

    Report Number
    2183460-1998-00078
    Event Type
    Injury
    Date Received
    November 6, 1998
    Date of Event
    September 17, 1998
    Report Date
    November 5, 1998
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A MEETING, REG AFFAIRS HEARD OF THIS INCIDENT. REG AFFAIRS FOLLOWED UP WITH SALES REP AFTER MEETING TO OBTAIN THE DETAILS. SALES REP HEARD OF CASE ABOUT A WEEK AFTER ANGIOJET CASE WAS PERFORMED; DISPOSABLES WERE DISCARDED. PT WAS PRESENTED WITH ACUTE MYOCARDIAL INFARCTION OF LARGE DOMINATE RIGHT CORONARY ARTERY. ANGIOJET WAS USED APPROX 8 MINS. BLOOD LOSS WAS APPROX 250CCS. CASE WAS SUCCESSFUL ALTHOUGH PT DID EXPERIENCE RENAL FAILURE POST PROCEDURE. PHYSICIAN WAS CONCERNED BUT NOTED OTHER FACTORS MAY HAVE CONTRIBUTED TO THIS OUTCOME - SUCH AS CONTRAST, REOPRO, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSSIS ANGIOJET LF 140 CATHETER THROMBECTOMY CATHETER DXE POSSIS MEDICAL, INC. LF140 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention