BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 3973477 · Received August 1, 2014

    Report

    Report Number
    1226348-2014-30057
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE UNKNOWN DEVICE WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE OF THE DEVICE WAS FOUND KINKED. NO OTHER OBVIOUS DAMAGES WERE NOTED ON THE RECEIVED DEVICE. THE CONCLUSION REMAINS THE SAME: 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.

    Additional Manufacturer Narrative · 1

    REVIEW OF DHR FOR LOT 15961281 CONCLUDED THAT NO ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT.THE FINAL ASSEMBLY INSPECTION WAS REVIEWED AND NO ANOMALIES WERE NOTED.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.

    Description of Event or Problem · 1

    THE SURGEON NOTED THE ORBIT GALAXY COIL (640HX0204/15961281) HAD STRETCHED DURING ADVANCEMENT DURING A PROCEDURE TO EMBOLIZE A 3X4 MM MIDDLE CEREBRAL ARTERY ANEURYSM. THE COIL WAS CHANGED. THERE WAS NO SIGNIFICANT DELAY TO THE PROCEDURE AS A RESULT OF THE ISSUE. NO ADVERSE EVENT OCCURRED. NO ADDITIONAL INTERVENTION WAS REQUIRED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED AT ALL TIMES. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND MICROCATHETER WHEN ACCESSING THE TARGET SITE. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. THIS IS THE FIRST COIL IN THE PROCEDURE. NO KINKS IN THE MICROCATHETER COULD HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED, REPOSITIONED, OR WITHDRAWN. THE MICROCATHETER WAS NO REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER. A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. IT IS NOT KNOWN WHETHER THE COIL WAS STILL ATTACHED TO THE DELIVERY TUBE AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450582 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA 15961281

    Patients

    Seq Age Sex Outcome Treatment
    1