BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 4087399 · Received September 13, 2014

    Report

    Report Number
    1226348-2014-00619
    Event Type
    Malfunction
    Date Received
    September 13, 2014
    Date of Event
    April 28, 2011
    Report Date
    May 3, 2011
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH THE DETACHMENT BUTTON WAS PRESSED SEVERAL TIMES; THE DELTAPLUSH CERECYTE MICROCOIL 2 MM X 4 CM (CPL10020430/G12690) COULD NOT BE DETACHED. SO IT WAS REMOVED SAFELY. USING THE SAME CABLE AND THE SAME DCB (DETAILS UNKNOWN); OTHER MICRUS COILS (DETAILS UNKNOWN) WERE DETACHED WITH NO PROBLEM. AN EXCELSIOR SL-10 MICROCATHETER (DETAILS UNKNOWN) WAS USED. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. THE AUDIBLE SIGNAL BEEPED. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE EXACT ROOT CAUSE OF THE PROBLEM COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY RELEVANT DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. 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: SAME CABLE AND THE SAME DCB (DETAILS UNKNOWN), MICRUS COILS (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    THOUGH THE DETACHMENT BUTTON WAS PRESSED SEVERAL TIMES; THE DELTAPLUSH CERECYTE MICROCOIL 2 MM X 4 CM (CPL10020430/G12690) COULD NOT BE DETACHED. SO IT WAS REMOVED SAFELY. USING THE SAME CABLE AND THE SAME DCB (DETAILS UNKNOWN); OTHER MICRUS COILS (DETAILS UNKNOWN) WERE DETACHED WITH NO PROBLEM. AN EXCELSIOR SL-10 MICROCATHETER (DETAILS UNKNOWN) WAS USED. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. THE AUDIBLE SIGNAL BEEPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567190 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G12690

    Patients

    Seq Age Sex Outcome Treatment
    1