BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1040379 · Received May 6, 2008

    Report

    Report Number
    1058196-2008-00125
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 10, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO INDICATED THAT THE PT WAS A FEMALE, AND DURING THE PROCEDURE, THERE WAS NO RESISTANCE/FRICTION BETWEEN THE COIL DELIVERY SYSTEM AND MICROCATHETER. DURING THE EVENT, THE COIL WAS NOT UTILIZED LIKE A GUIDEWIRE, MEANING THE COIL WAS NOT ADVANCE INTO THE ANEURYSM AND THEN FOLLOWED BY THE MICROCATHETER. THE VESSEL WAS NOT CALCIFIED BUT WAS TORTUOUS. THE ANEURYSM LOCATION WAS IN THE (ACOM) ANTERIOR COMMUNICATING ARTERY. THERE WAS NO ADD'L INFO. THE PRODUCT REMAINS IMPLANTED. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    A 2X2 ORBIT COIL STRETCH. IT WAS THE LAST COIL THAT WAS PLACED IN THE ANEURYSM, BUT THE COIL WAS ABLE TO PUT THE COIL IN THE ANEURYSM SO THERE IS NO PRODUCT TO BE RETURNED. THERE WAS NO PT INJURY AND THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 13347315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNKNOWN BRAND MICROCATHETER