BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUX VENA CAVA FILTER SYSTEM

    MDR report key: 4152498 · Received October 6, 2014

    Report

    Report Number
    2939520-2014-00083
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Product Code
    DTK
    PMA / PMN Number
    K122585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETAINED BY THE HOSP FOR FURTHER EVAL. HOWEVER, A FULL EVAL WILL BE CONDUCTED IF THE DEVICE IS RETURNED TO THE MANUFACTURER AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODE VIA OUR STANDARD COMPLAINT REVIEW PROCESS AND DATA TRENDING ACTIVITIES.

    Description of Event or Problem · 1

    DURING FILTER REMOVAL, THE PHYSICIAN INITIALLY TRIED TO REMOVE THE DEVICE VIA A JUGULAR APPROACH BUT WAS UNSUCCESSFUL. HE THEN CHANGED THE APPROACH TO FEMORAL RETRIEVAL USING A COOK AND IVD FILTER RETRIEVAL SET. AS THEY WERE TAKING AN 11 FRENCH CATHETER TO COLLAPSE THE FILTER, THE CRANIAL HOOK OF THE FILTER DISSECTED THE OUTER CATHETER AT ABOUT 10CM IN LENGTH. NO INJURY WAS CAUSED BUT THE DOCTOR HAD TO MANEUVER THE FILTER SO AS NOT TO CAUSE ANY INJURY TO THE PT. THE FILTER WAS SUCCESSFULLY REMOVED AND THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622274 CRUX VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK 7025 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1