BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCS 18 3X10 HELICAL FILL

    MDR report key: 834889 · Received January 31, 2007

    Report

    Report Number
    1058196-2007-00043
    Event Type
    Malfunction
    Date Received
    January 31, 2007
    Date of Event
    July 2, 2004
    Report Date
    July 5, 2004
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    k014041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM, HOWEVER IT WAS STRETCHED. THE COIL INTRODUCER WAS ALSO IN PLACE AND THERE WERE TRACES OF DRY BLOOD VISIBLE INSIDE THE COIL INTRODUCER. NO DAMAGE WAS VISIBLE ON THE BODY OR THE HUB. A REVIEW OF ROUTE SHEETS WAS NOT PERFORMED FOR THIS PRODUCT AS THE COMPLAINT DOES NOT APPEAR TO BE MANUFACTURING RELATED. THE CAUSE OF THE DIFFICULTY OF INSERTING THE LAST COILS COULD NOT BE DETERMINED. THE STRETCHED COIL IS EVIDENCE OF INSERTION/WITHDRAWAL DIFFICULTIES. IT WAS REPORTED THAT THE COIL INSERTION DIFFICULTY OCCURRED AFTER SUCCESSFUL PLACEMENT OF SIX COILS. IN ORDER TO MAINTAIN LUBRICITY OF THE INNER LUMEN OF THE MICROCATHETER, THE IFU INSTRUCTS THAT A CONTINUOUS FLUSH MUST BE MAINTAINED. THE FLUSH RATE MUST BE MONITORED AFTER INTRODUCTION OF THE COIL INTRODUCER INTO THE MICROCATHETER TO ENSURE THAT AN ADEQUATE FLUSH IS MAINTAINED. THIS A POSSIBLE CONTRIBUTING FACTOR TO THE REPORTED INABILITY TO INSERT THE COILS INTO THE MICROCATHETER RESULTING IN COIL DAMAGE. THE MICROCATHETER WAS NOT RETURNED FOR ANALYSIS; THEREFORE NO CONCLUSION CAN BE MADE. THIS IS ONE OF FOUR PRODUCTS USED ON THE SAME PT. MFR. REPORT #1058196-2007-000041, #1058196-2007-000042, #1058196-2007-000044.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION WITHIN UNKNOWN ANEURYSM, THE PHYSICIAN PLACED A 7MM, 6MM, AND 5MM (TOTAL OF SIX UNITS) COILS USING THIS MICROCATHETER WITHOUT ANY DIFFICULTY. FOLLOWING THE PROCEDURE, HE COULD NOT ADVANCE THE 4MM AND 3MM COILS INTO THE RAPID TRANSIT MICROCATHETER (MC). THE MC WAS WITHDRAWN FROM THE PT'S VESSEL. OUTSIDE THE PT, HE TRIED AGAIN TO ADVANCE THE COIL INTO THE MC, BUT THE COIL REMAINED INSIDE THE MC. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT. REVIEW OF THE ANALYSIS PERFORMED ON THE RETURNED PRODUCT DETERMINED THAT THERE WAS A REPORTABLE PRODUCT MALFUNCTION THAT WAS NOT EVIDENT FROM THE INFORMATION PROVIDED BY THE CUSTOMER. THE COIL WAS RECEIVED STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCS 18 3X10 HELICAL FILL CNV DCS COILS (HCG) HCG CORDIS NEUROVASCULAR, INC. NA D1001054

    Patients

    Seq Age Sex Outcome Treatment
    1 * MC