BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU

    MDR report key: 1062978 · Received June 18, 2008

    Report

    Report Number
    9610978-2008-00153
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 26, 2008
    Report Date
    May 27, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K023116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. FILMS HAVE BEEN FORWARDED FOR REVIEW. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. UNTIL THE FILM REVIEW IS COMPLETED THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    THE FILTER WAS IMPLANTED IN 2007 FOR DVT. WHEN THE PATIENT WAS INSPECTED IN 2008, THE PHYSICIAN FOUND ONE CONNECTING STRUT OF THE FILTER TO BE FRACTURED. NO ADDITIONAL INTERVENTIONS ARE PLANNED AT THIS TIME. THERE IS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK) DTK CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR