BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 1181507 · Received September 25, 2008

    Report

    Report Number
    1058196-2008-00229
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS PRIOR THE SAME PROCEDURE. MFR REPORT#1058196-2008-00227 & 1058196-2008-00228.

    Description of Event or Problem · 1

    THE ORBIT COIL DETACHED PREMATURELY. THIS PATIENT WAS UNDERGOING COIL EMBOLIZATION WITHIN THE HEPATIC ARTERY (AN OFF-LABEL USE FOR TRUFILL COILS). THE COIL DETACHED PREMATURELY IN THE MICROCATHETER. DURING INTRODUCTION OF THE DELIVERY SYSTEM, A SNAG WAS FELT BY THE PHYSICIAN. SINCE THE DELIVERY SYSTEM WAS EXPECTED TO FLOW SMOOTHLY, HE WAS ADVISED NOT TO PUSH FURTHER AND WITHDRAW THE WHOLE THING AND INSPECT WHAT CAUSED THE SNAG. UPON CHECKING, HE NOTED COIL HAD DETACHED PREMATURELY. THIS HAPPENED THREE TIMES. REPORTEDLY, IT WAS THE SURGEON'S CLINICAL DECISION TO USE TRUFILL COIL IN SPITE OF HIS FULL KNOWLEDGE THAT TRUFILL COIL IS INTENDED FOR INTRACRANIAL ANEURYSM. HIS OTHER OPTION WAS TO USE VORTEX PUSHABLE COIL BY BOSTON SCIENTIFIC, BUT PER PREVIOUS EXPERIENCE, THE PUSHABLE COIL EMBOLIZED ON UNINTENDED SITE. THE DELIVERY SYSTEM WAS INSPECTED UPON REMOVAL FROM THE PACKAGING AND NO KINK/COMPRESSION WAS NOTED. THE DELIVERY SYSTEM WAS INTRODUCED VERY SLOWLY INTO THE MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    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. NA 13251246

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK