BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 1023794 · Received April 1, 2008

    Report

    Report Number
    1058196-2008-00089
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS TO BE RETURNED FOR EVALUATION AND TESTING. PLEASE NOTE ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    COIL STRETCHED. THIS PT WAS UNDERGOING COIL EMBOLIZATION WITHIN THE ANEURYSM; THREE MICRUS PRESIDIO COILS WERE PLACED. DURING PLACING THE FOURTH ORBIT COIL IN THE ANEURYSM, THE COIL PREMATURELY STRETCHED. NO RESISTANCE WAS FELT WHILE ADVANCING THE FOURTH COIL INTO THE ECHELON 10 MICROCATHETER. THE COIL WAS PARTIALLY INSIDE THE ANEURYSM WHEN THE PHYSICIAN NOTED, THERE WAS NO ONE TO ONE RELATIONSHIP. THE COIL WAS NOT REPOSITIONED. THE COIL DID NOT PREMATURELY DETACH, IT STRETCHED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. MA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ECHELON 10 MICROCATHETER