BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 2173969 · Received July 24, 2011

    Report

    Report Number
    3007628272-2011-50018
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE ORBIT GALAXY COMPLEX XTRASOFT COIL 2X2 WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL AND GRIPPER WAS FOUND INSIDE OF THE INTRODUCER WITHOUT DAMAGE. THE EMBOLIC COIL WAS RECEIVED SEPARATED FROM THE DEVICE INSIDE OF A ZIPLOC BAG AND IT WAS FOUND WITHOUT DAMAGE. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON THEM. THE MARKS OF THE EMBOLIC COIL ARE OBSERVED WITHIN THE GRIPPER INDICATING A TIGHT PRESS FIT. THE PURGE HOLE OF THE GRIPPER WAS INSPECTED AND IT WAS FOUND WITHOUT DAMAGE OR OBSTRUCTION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED DETACHMENT OF THE COIL WAS CONFIRMED; THE COIL WAS RECEIVED SEPARATED FROM THE DEVICE. BASED ON THE AVAILABLE PROCEDURAL INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE, NO CONCLUSION CAN BE MADE REGARDING THE CONDITIONS OF THE RETURNED DEVICE OR REPORTED EVENT. HOWEVER, WITH REVIEW OF THE ANALYSIS OF THE RETURNED DEVICE AND DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. ADDITIONALLY, INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED DEVICES FROM LEAVING THE FACILITY. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE 2X2 TRUFILL DCS ORBIT GALAXY XTRASOFT COIL PREMATURELY DETACHED WHEN IT WAS PURGED FOR THE FIRST TIME WITH A TRUFILL DCS SYRINGE II DURING PREP. IT IS UNKNOWN IF THE HUB OF THE ORBIT DELIVERY TUBE HAD BEEN FLUSHED PRIOR TO CONNECTING THE DCS SYRINGE, WHICH THE INSTRUCTIONS FOR USE WARNS AGAINST. THE SYRINGE PRESSURE WAS NEVER INCREASED ABOVE THE RED LINE BEYOND POSITION 1 (BLUE) ZONE DURING PREP. IT IS UNKNOWN IF THE COIL CAUGHT ON ANYTHING OR IF UNINTENTIONAL PULLING OF THE COIL CONTRIBUTED TO THE PREMATURE DETACHMENT. THE COIL WAS NOT CLINICALLY USED, AND THE PROCEDURE WAS COMPLETED USING OTHER UNKNOWN PRODUCTS. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PRIOR TO THE EVENT, THREE ORBIT COILS WERE SUCCESSFULLY PLACED AT THE TARGET ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA 13500219

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR UNK DCS SYRINGE