BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALN EXTRACTION KIT

    MDR report key: 2857745 · Received November 15, 2012

    Report

    Report Number
    3007080617-2012-00004
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    June 1, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ALN
    Product Code
    DTK
    PMA / PMN Number
    K070514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EFFORTS TO OBTAIN CT SCANS TAKEN DURING THE PROCEDURE FOR EXAMINATION WERE UNSUCCESSFUL. AS MEDICAL IMAGES COULD NOT BE EXAMINED, IT WAS NOT POSSIBLE TO DETERMINE IF THE INCIDENT WAS ATTRIBUTED TO THE DEVICE OR ANOTHER FACTOR SUCH AS THE INEXPERIENCE OF THE PHYSICIAN USING THE RETRIEVAL KIT. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO RETRIEVE THE ALN FILTER USING THE ALN RETRIEVAL PINCER IN THE IR SUITE. HOWEVER, THE RETRIEVAL PINCER COULD NOT ADEQUATELY GRAB THE FILTER. RETRIEVAL WAS ATTEMPTED FOR 2, 5 HOURS WITH VARIOUS TECHNIQUES, BUT THE FILTER COULD NOT BE RE-SHEATHED. THE ALN FILTER REMOVAL WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALN EXTRACTION KIT EXTRACTION KIT DTK ALN FT.200001

    Patients

    Seq Age Sex Outcome Treatment
    1