BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 2843007 · Received November 21, 2012

    Report

    Report Number
    3007628272-2012-50083
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 5, 2012
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO FAILURE ON THIS DEVICE. THEREFORE, PLEASE NOTE THAT THIS PARTICULAR DEVICE/EVENT WILL BE VOIDED.

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THE TARGET SITE WAS INTERNAL ILIAC ARTERY PRIOR TO STENT GRAFTING THAT WAS MILDLY CALCIFIED AND HEAVILY TORTUOUS. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION, BUT NOT THE ORBIT THAT SEPARATED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, NO ANALYSIS NOR DHR COULD BE CONDUCTED. BASED ON THE AVAILABLE INFORMATION, AND WITHOUT THE DEVICE, THE REPORT EVENT OF SEPARATED DELIVERY TUBE COULD NOT BE CONFIRMED. ADDITIONALLY, THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO DHR COULD BE CONDUCTED. THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE CATALOG AND LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, THEREFORE THE DEVICE NOTED (UNK GALAXY) REPRESENTS AN ORBIT GALAXY COIL THAT THE CATALOG NUMBER BEGINS WITH 640. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 3007628272-2012-50082 AND 3007628272-2012-50083.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION PROCEDURE, THE ORBIT GALAXY ((B)(4)) WOULD NOT DETACH AT THE GREEN ZONE USING AN UNSPECIFIED DCS SYRINGE II. IT IS UNKNOWN IF THE ALTERNATIVE DETACHMENT WAS ATTEMPTED. THEREFORE, THE ORBIT GALAXY WAS SAFELY REMOVED FROM THE PATIENT AND WAS REPLACED FOR A NEW ORBIT GALAXY (CATALOG AND LOT UNKNOWN) THAT COULD BE DETACHED WITHOUT ANY DIFFICULTIES. HOWEVER, WHEN DELIVERY SYSTEM WAS PULLED BACK, ABOUT 10CM FROM THE PROXIMAL END OF THE DELIVERY TUBE APPEARED TO BE DAMAGED AND SEPARATED IN TWO PIECES. THE DISTAL PIECE OF THE DELIVERY TUBE WAS FOUND IN THE PROGREAT (MC) MICROCATHETER AND WAS ALSO SAFELY REMOVED. IT IS UNKNOWN WHERE AND WHEN EXACTLY IT WAS OCCURRED. THE DEVICE WAS NOT SEPARATED OR DAMAGED PRIOR TO USE, AND THERE WAS NO RESISTANCE DURING DELIVERY OF THE DEVICE THROUGH THE INTRODUCER, Y CONNECTOR OR MICROCATHETER. IT IS UNKNOWN IF THE SAME DCS SYRINGE II WAS USED WITH THE NEXT DEVICE, AND ALSO UNKNOWN HOW MANY OTHER COILS WERE DETACHED WITH THE SAME SYRINGE. PRIOR TO THE ORBIT GALAXY (B)(4), THE SYRINGE WAS TAKING PASSED THE GREEN ZONE, BUT IS UNKNOWN HOW MANY TIMES. A DEDICATED SALINE SOURCE WAS USED TO FILL THE SYRINGE, AND ALL THE CONNECTIONS WERE CHECKS FOR PROPER FITTING. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY/COMPLICATION WAS REPORTED. PRIOR TO THE COMPLAINT PRODUCT, NINE COILS WERE PLACED IN THE ANEURYSM WITHOUT ANY DIFFICULTIES. IT IS ALSO UNKNOWN BOTH THE DCS SYRINGE II AND THE PROGREAT MC (TERUMO, UNSPECIFIED) WERE REPLACED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORBIT GALAXY DETACHABLE COIL SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGE II AND PROGREAT MICROCATHETER