BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMON NITINOL FILTER 2220

    MDR report key: 108478 · Received July 25, 1997

    Report

    Report Number
    1222632-1997-00077
    Event Type
    Malfunction
    Date Received
    July 25, 1997
    Date of Event
    June 26, 1997
    Report Date
    July 25, 1997
    Manufacturer
    NITINOL MEDICAL TECHNOLOGIES, INC.
    Product Code
    DTK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FILTER FEET GOT STUCK AT INTRODUCER HUB JUNCTION. THE DELIVERY SYSTEM WAS REMOVED AND THE DOCTOR CUT THE INTRODUCER TO MANUALLY FEED THE FILTER TO THE TARGETED LOCATION. NO FURTHER COMPLICATIONS REPORTED. 2ND OF 2 REPORTS INVOLVING SAME PATIENT REPORT 1222632-1997-00076).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMON NITINOL FILTER 2220 Implant VENA CAVA FILTER DTK NITINOL MEDICAL TECHNOLOGIES, INC. 2220 518126A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO