BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SORIN

    MDR report key: 109497 · Received July 30, 1997

    Report

    Report Number
    MW1011792
    Event Type
    Injury
    Date Received
    July 30, 1997
    Date of Event
    July 9, 1997
    Report Date
    July 23, 1997
    Manufacturer
    SORIN BIOMEDICAL INC.
    Product Code
    DXE
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING DECLOTTING OF BRACHIAL ARTERY OF PT. WITH PTFE GRAFT, PHYSICIAN FELT RESISTANCE IN CATHETER, RELEASED BALLOON, PULLED BACK, AGAIN FELT RESISTANCE AND ADVANCED CATHETER WHICH CAME FREE. NO PROBLEM WITH FLOW. CATHETER NOTED TO BE MISSING BALLOON. ALL VESSELS OPEN PER SUBSEQUENT RADIOLOGY EXAM. NO CLINICAL SEQUELAE. GRAFT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORIN ARTERIAL EMBOLECTOMY CATHETER DXE SORIN BIOMEDICAL INC. 4EMB80 SIZE 4F 9580509078

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R