BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM

    MDR report key: 5291342 · Received December 11, 2015

    Report

    Report Number
    2954740-2015-00277
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    November 16, 2015
    Report Date
    November 16, 2015
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K120686
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE G2 COMPLEX WILL NOT BE RETURNED, THEREFORE THE COIL'S NON-DETACHMENT INSIDE THE TARGET SITE CANNOT BE DETERMINED. DHR: 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. BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE CONTACT FROM THE FACILITY REPORTED THAT THE PHYSICIAN WANTED TO DETACH THE ORBIT GALAXY G2 MICROCOIL (641CX2535/P10034) IN THE ANEURYSM BUT COULD NOT. HE TRIED PRESSING THE DETACH BUTTON AGAIN BUT IT STILL DID NOT WORK. THE PHYSICIAN RESHEATHED THE MICROCOIL AND USED ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AT THE TIME OF INITIAL CONTACT THE DEVICE WAS NOT KEPT AND WAS AVAILABLE FOR RETURN. THERE WAS NO SIGNIFICANT DELAY TO THE PROCEDURE AS A RESULT OF THE ISSUE. THERE WERE NO DAMAGES NOTED ON THE DEVICE PRIOR TO USE OR AFTER REMOVAL. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT, STILL ATTACHED TO THE DELIVERY SYSTEM, AND NOT STRETCHED. AN ENPOWER DETACHMENT CONTROL BOX AND CONNECTING CABLE (BOTH DETAILS UNKNOWN) WERE USED IN THE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO LOW BATTERY LIGHT WAS SEEN DURING THE CASE. THERE WAS NO FAULT LIGHT 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 AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME CONNECTING CABLE WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE SAME DCB WAS USED WITH SUBSEQUENT COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819858 ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL P10034

    Patients

    Seq Age Sex Outcome Treatment
    1