BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL FILTER

    MDR report key: 8824305 · Received July 24, 2019

    Report

    Report Number
    2020394-2019-01842
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED. THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED PERFORATION OF THE IVC, MIGRATION, TILT AND FILTER DETACHMENT AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT AN UNKNOWN MODEL VENA CAVA FILTER ALLEGEDLY EXPERIENCED A DEVICE OR COMPONENT MIGRATION, DEVICE MALPOSITION, DETACHMENT OF THE DEVICE OR A COMPONENT, AND A PATIENT-DEVICE INTERACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616399 NITINOL FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1