BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 2994367 · Received March 8, 2013

    Report

    Report Number
    1226348-2013-10017
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE ORBIT GALAXY COMPLEX XTRASOFT COIL 2 X 2 WAS RECEIVED COILED INSIDE OF PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS RECEIVED UNZIPPED AND IT WAS FOUND WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE JUST THE HEAD PIECE OF THEE EMBOLIC COIL WAS FOUND ATTACHED TO THE GRIPPER WHILE THE REST OF THE EMBOLIC COIL WAS FOUND STRETCHED AND BROKEN. THE GRIPPER AND THE HEADPIECE WERE INSPECTED UNDER MICROSCOPE. THE GRIPPER WAS FOUND WITHOUT DAMAGE. THE SOLDERED SECTION BETWEEN HEADPIECE AND THE COIL LOOPS WAS NOT FRACTURED SO THIS MEANS THAT THE SOLDER HAD A GOOD ADHESION TO THE HEADPIECE. THE REST OF THE EMBOLIC COIL WAS FOUND STRETCHED AND THE SUTURE APPEARS TO BE ELONGATED BEFORE IT WAS BROKE. 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. SOME OTHER DAMAGES WERE FOUND DURING THE ANALYSIS THAT APPEARED TO OCCUR DURING THE HANDLING OF THE UNIT WHEN IT WAS RETURNED FOR EVALUATION. THE EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND THE STRETCHED CONDITION WAS CONFIRMED. 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 STRETCHED COIL WAS CONFIRMED WITH ANALYSIS OF THE RETURNED DEVICE. THE CAUSE OF THE KINKS ON THE DEVICE AND THE STRETCHED EMBOLIC COIL COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, WITH REVIEW OF THE ANALYSIS AND DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY RELATIONSHIP TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURE FROM LEAVING THE FACILITY. IT IS POSSIBLE THAT ANEURYSM/VESSEL CHARACTERISTICS AND THE PROCEDURAL FACTOR OF REPOSITIONING THE MICROCATHETER OVER THE PARTIALLY DEPLOYED COIL, WHICH THE INSTRUCTIONS FOR USE CAUTIONS MAY LEAD TO COIL DAMAGE, MAY HAVE CONTRIBUTED. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION PROCEDURE OF THE INTERNAL CAROTID ARTERY ANEURYSM, WHILE ADVANCING AN ORBIT GALAXY COMPLEX XTRASOFT COIL ((B)(4)/15745003) IN AN UNSPECIFIED EXCELSIOR SL10 MICROCATHETER (STRYKER, TYPE UNKNOWN), THE COIL UNRAVELED IN THE MICROCATHETER. ACCORDING TO THE INFORMATION PROVIDED, WHEN THE COIL UNRAVELED, IT WAS NEVER PULLED BACK INTO THE MICROCATHETER. THEREFORE, THE ENTIRE ORBIT GALAXY WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS CONTINUED USING AN UNSPECIFIED COMPETITOR'S PRODUCT (TARGET/STRYKER). AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY/COMPLICATION WAS REPORTED. IT IS UNKNOWN IF THE MICROCATHETER WAS REPLACED OR NOT. THE COMPLAINT PRODUCT WAS NEW AND WAS 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 PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THE UNINTENDED DETACHMENT WAS NOT OBSERVED IN THE ANEURYSM OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE VESSEL WAS MILDLY TORTUOUS BUT THE LEVEL OF CALCIFICATION WAS UNKNOWN. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99694 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA 15745003

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR SL10 MICROCATHETER