BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 2921626 · Received January 18, 2013

    Report

    Report Number
    2954740-2013-00016
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 26, 2012
    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

    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. WITHOUT THE DEVICE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CIRCUMSTANCES OF HOW AND WHY THE DEVICE FAILED DURING PRE-DEPLOYMENT CHECK CANNOT BE DETERMINED. 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. NO DEFINITIVE CONCLUSION CAN BE MADE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE EVENT HAPPENED DURING PREPARATION, PRIOR TO DETACHING THE DELTAPLUSH MICROCOIL ((B)(4)) IN THE PATIENT, DURING PRE-DEPLOYMENT ELECTRICAL CHECK USING AN ENPOWER CONTROL CABLE (CATALOGUE AND LOT NUMBER UNKNOWN), THE GREEN SYSTEM READY LIGHT OF THE DETACHMENT CONTROL BOX (LOT UNKNOWN) DID NOT ILLUMINATE. AFTER THE EVENT, THE DEVICE WAS REPLACED WITH A NEW DELTAPLUSH MICROCOIL (LOT UNKNOWN), THE SYSTEM READY LIGHT ILLUMINATED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE DEVICE BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THE PROCEDURE WAS COIL EMBOLIZATION OF UNSPECIFIED ARTERY RUPTURED ANEURYSM. THE VESSEL CHARACTERISTICS WERE NOT PROVIDED, AND NOR PATIENT INFORMATION WAS PROVIDED. ACCESS WAS OBTAINED FROM FEMORAL ARTERY. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27678 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G10257

    Patients

    Seq Age Sex Outcome Treatment
    1 ENPOWER CONTROL CABLE AND DETACHMENT CONTROL BOX