BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMON NITINOL FILTER 2120

    MDR report key: 89635 · Received May 9, 1997

    Report

    Report Number
    1222632-1997-00039
    Event Type
    Injury
    Date Received
    May 9, 1997
    Date of Event
    April 10, 1997
    Report Date
    May 8, 1997
    Manufacturer
    NITINOL MEDICAL TECHNOLOGIES, INC.
    Product Code
    DTK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INTRODUCER/WIRE MISMATCH: "WIRE WOULDN'T GO THROUGH BLUE DILATOR. USED COOK 15MM "T" CURVED NEWTON LLT .038" WIRE. REMOVED AND REPLACED WIRE TO COMPLETE PROCEDURE SUCCESSFULLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMON NITINOL FILTER 2120 Implant VENA CAVA FILTER DTK NITINOL MEDICAL TECHNOLOGIES, INC. 2120 521017A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention