BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXTER FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 35157 · Received July 3, 1996

    Report

    Report Number
    35157
    Event Type
    Other
    Date Received
    July 3, 1996
    Date of Event
    April 2, 1996
    Report Date
    April 5, 1996
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD EMBOLECTOMY FOR RIGHT ARM AV SHUNT CLOT. DURING PROCEDURE, SMALL PIECE OF CATHETER/BALLOON BROKE OFF IN PT. X-RAY TAKEN IN OR. COULD NOT VISUALIZE BALLOON. PT HAD SUCCESSFUL DIALYSIS AFTER SURGERY-SHUNT WORKED-SENT BACK TO CONVALESCENT HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER FOGARTY ARTERIAL EMBOLECTOMY CATHETER FOGARTY ARTERIAL EMBOLECTOMY CATHETER DXE BAXTER HEALTHCARE CORP. 120404F 5S041

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other