BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - PLATINUM MICROCOIL

    MDR report key: 4067779 · Received September 8, 2014

    Report

    Report Number
    1226348-2014-00414
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    September 2, 2010
    Report Date
    September 3, 2010
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELTAPLUSH PLATINUM MICROCOIL 2 MM X 6 CM (DPL10020620/G11098) AND THE CABLE ARE GRIPPED SO TIGHTLY THAT IT IS IMPOSSIBLE TO SEPARATE THEM. SO THEY HAD TO TAKE A NEW CABLE AND A NEW COIL (DETAILS UNKNOWN) TO CONTINUE TO COIL. THE RETURNED ECB PASSED ALL FUNCTIONALITY TESTING AND WAS NOT THE ROOT CAUSE OF THIS COMPLAINT. THE MOST LIKELY ROOT CAUSE OF THE DEVICE POSITIONING UNIT'S (DPU) FAILURE TO CONNECT INTO THE ENPOWER CONTROL CABLE (ECB) WAS DUE TO THE MISALIGNMENT OF THE DPU'S ELECTRICAL CONNECTOR'S POSTS AND THE MISSING LEAD-IN CHAMFER LOCATED AT THE INSIDE DIAMETER OF BOTH ELECTRICAL POSTS. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS THE RESULT OF A RECENT FDA AUDIT AND WITH ACCORDANCE TO THE REQUIREMENTS OF CODE OF FEDERAL REGULATIONS ¿ 21 CFR PART 803, MEDICAL DEVICE REPORTING. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: NEW CABLE AND A NEW COIL (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    THE DELTAPLUSH PLATINUM MICROCOIL 2 MM X 6 CM (DPL10020620/G11098) AND THE CABLE ARE GRIPPED SO TIGHTLY THAT IT IS IMPOSSIBLE TO SEPARATE THEM. SO THEY HAD TO TAKE A NEW CABLE AND A NEW COIL (DETAILS UNKNOWN) TO CONTINUE TO COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548893 DELTAPLUSH - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G11098

    Patients

    Seq Age Sex Outcome Treatment
    1