BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - PLATINUM MICROCOIL

    MDR report key: 4086024 · Received September 12, 2014

    Report

    Report Number
    1226348-2014-00529
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    October 28, 2010
    Report Date
    November 1, 2010
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DELTAPLUSH PLATINUM MICROCOIL 3 MM X 6 CM (DPL10030620/G11265) DOES NOT DETACH. THE CONNECTION BETWEEN THE COIL AND CABLE WAS A BIT LOOSE. THE COIL WAS REMOVED AND ANOTHER COIL (DETAILS UNKNOWN) WAS USED. A PRE-DEPLOYMENT TEST WAS NOT PERFORMED. AN SL-10 MICROCATHETER (DETAILS UNKNOWN) WAS USED. THE DEVICE POSITIONING UNIT'S (DPU) ELECTRICAL CONNECTOR WAS RETURNED DESTROYED WITH MULTIPLE COMPONENTS MISSING INCLUDING THE LEFT ELECTRICAL POST AND WIRE. NO ELECTRICAL TESTING COULD BE PERFORMED. THEREFORE, THE ROOT CAUSE OF THE COIL UNABLE TO BE DETACHED CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM, INCLUDING THE DETACHMENT CONTROL BOX (DCB), THE CONNECTING CABLE, AND AN INTACT DEVICE POSITIONING UNIT'S (DPU) ELECTRICAL CONNECTOR, IT CANNOT BE DETERMINED IF THIS COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. BASED ON THE INFORMATION AND THE ANALYSIS, THE EVENT COULD NOT BE CONFIRMED. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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 COIL (DETAILS UNKNOWN) MICROCATHETER (DETAILS UNKNOWN) DETACHMENT CONTROL BOX (DETAILS UNKNOWN) CONNECTING CABLE (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    DELTAPLUSH PLATINUM MICROCOIL 3 MM X 6 CM (DPL10030620/G11265) DOES NOT DETACH. THE CONNECTION BETWEEN THE COIL AND CABLE WAS A BIT LOOSE. THE COIL WAS REMOVED AND ANOTHER COIL (DETAILS UNKNOWN) WAS USED. A PRE-DEPLOYMENT TEST WAS NOT PERFORMED. AN SL-10 MICROCATHETER (DETAILS UNKNOWN) WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564158 DELTAPLUSH - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G11265

    Patients

    Seq Age Sex Outcome Treatment
    1