BEUDAMED
    FDA Adverse Event Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 4060191 · Received September 4, 2014

    Report

    Report Number
    1226348-2014-00343
    Date Received
    September 4, 2014
    Date of Event
    February 17, 2011
    Report Date
    February 17, 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

    (B)(6). COMPLAINT CONCLUSION: THE COIL WAS RETURNED UNSHEATHED AND UNPROTECTED. THE RESHEATHING TOOL WAS ADVANCED OVER THE PROXIMAL END OF THE GREEN INTRODUCER. THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. USING THE RETURNED CONNECTING CABLE AND THE MICROCOIL SYSTEM, THE COIL WAS DETACHED ON THE FIRST DETACHMENT CYCLE. THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING. USING THE BOTH THE CONNECTING CABLE AND THE COIL FROM THE PROCEDURE; THE COIL DETACHED ON THE FIRST DETACHMENT CYCLE. THEREFORE; THE ROOT CAUSE OF THE COIL BEING UNABLE TO BE DETACHED CANNOT BE DETERMINED. IN ADDITION; WITHOUT THE RETURN OF THE DETACHMENT CONTROL BOX (DCB) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT, NO CORRECTIVE ACTIONS WERE TAKEN. 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.

    Description of Event or Problem · 1

    A DELTAPLUSH COIL FAILED TO DETACH. THE CONTROL BOX WAS RESTARTED AND THE CABLE WAS REPLACED, BUT THE COIL WOULD NOT DETACH AFTER APPROXIMATELY 5 ATTEMPTS. EVEN THOUGH THERE WAS NO PROBLEM WITH THE DISPLAY ILLUMINATION, THE COIL COULD NOT BE DETACHED. THE COIL WAS RETRIEVED FROM THE SL-10 MICROCATHETER AND OTHER COILS WERE SUCCESSFULLY IMPLANTED. BEFORE THIS PROBLEM, OTHER MICRUS COILS WERE DEPLOYED WITHOUT ANY PROBLEMS USING SAME CABLE AND ECB. BECAUSE THE SYSTEM FAULT LAMP ILLUMINATED; THE CABLE WAS REPLACED BY NEW ONE. THERE WAS NO SERIOUS INJURY OR REQUIRED INTERVENTION AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540625 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G12584

    Patients

    Seq Age Sex Outcome Treatment
    1