BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUX VENA CAVA FILTER SYSTEM

    MDR report key: 3938921 · Received June 10, 2014

    Report

    Report Number
    2939520-2014-00046
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    K122585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. IN ADDITION, THE COMPLAINT DATABASE WAS REVIEWED AND THERE ARE NO ADDITIONAL REPORTS OF THIS TYPE WERE FOUND FOR THIS LOT. PER THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED TO REMOVE THE DELIVERY CATHETER FROM THE PATIENT (POST DEPLOYMENT) SUCH THAT THE TIP IS CAREFULLY PULLED THROUGH THE DEPLOYED FILTER. THE USER IS ALSO CAUTIONED TO ENSURE THAT THE DELIVERY CATHETER DOES NOT INTERACT WITH THE DEPLOYED FILTER DURING WITHDRAWAL TO PREVENT SHIFTING OF THE FILTER. VOLCANO IS IN THE PROCESS OF CONDUCTING A CLINICAL ASSESSMENT OF THE POTENTIAL FOR PATIENT HARM AS WELL AS AN ENGINEERING EVALUATION OF THE SPECIFIC DEVICE INVOLVED IN THIS CASE. THE RESULTS OF THE CLINICAL ASSESSMENT AND ENGINEERING EVALUATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT ONCE AVAILABLE.

    Description of Event or Problem · 1

    THE USER SUCCESSFULLY DEPLOYED A CRUX VENA CAVA FILTER, AND DURING THE REMOVAL OF THE DELIVERY CATHETER THE DELIVERY SYSTEM TIP BECAME ENTRAPPED ON THE FILTER WEB. DESPITE THE USER'S ATTEMPT TO DISLODGE THE DELIVERY CATHETER, THE FILTER WAS PULLED INTO A MALPOSITION WHICH REQUIRED THE USER TO RETRIEVE THE DEVICE. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS SENT BY THE FACILITY TO VOLCANO CORPORATION FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343394 CRUX VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK VOLCANO CORPORATION 7024 0252 20005034

    Patients

    Seq Age Sex Outcome Treatment
    1