BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - PLATINUM MICROCOIL

    MDR report key: 2870928 · Received December 12, 2012

    Report

    Report Number
    2954740-2012-00820
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROXIMAL END OF THE COIL WAS FOUND PROTRUDING OUTSIDE THE SHEATH IN A STRETCHED AND COMPRESSED STATE. NO MECHANICAL SHEATH DAMAGE WAS FOUND. THE COIL'S SOCKET RING WAS FOUND PUSHED DOWN INSIDE THE PET OUTER SHEATH. THE MOST LIKELY ROOT CAUSE OF THE COIL BECOMING STUCK IN THE MICROCATHETER'S HUB MAY HAVE BEEN DUE TO DISTAL INTERFERENCE. IT CANNOT BE DETERMINED IF THERE WAS A MISALIGNMENT OF THE GREEN INTRODUCER TO THE HUB¿S FUNNEL. ALSO, THE SOURCE OF THIS INTERFERENCE; WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE SL-10 MICROCATHETER AND THE UNIDENTIFIED ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. NOTE: ADDITIONAL INFORMATION AND EVALUATION CODES WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    PER RECEIVED REPORT, COIL WOULD NOT THRU MICROCATHETER HUB. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL GOT STUCK IN THE MICROCATHETER'S HUB. THE ENTIRE COIL WAS SAFELY WITHDRAWN. THE MICROCATHETER WAS NOT REPLACED AT ANY TIME DURING THE PROCEDURE. AND THERE WAS NO LOSS OF TARGET POSITION IN THE INTRA-CRANIAL VASCULATURE. THERE WAS NO STRETCHING OR PREMATURE DETACHMENT OCCURRED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE PROCEDURE WAS NOT COMPLETED. FINAL ANALYSIS FOUND COMPRESSED AND STRETCHED COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTAPLUSH - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G14686

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKOWN SL-10 MICROCATHETER.| UNKOWN SL-10 MICROCATHETER