BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 4182974 · Received October 17, 2014

    Report

    Report Number
    3008264254-2014-20005
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 24, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. NO CONCLUSIONS ARE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A NON-STERILE OG TDL CMPLX FILL COIL 8X24 WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS FOUND ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED AND THE SUTURE OF IT WAS FOUND BROKEN. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE; NO OBSTRUCTIONS OR DAMAGES WERE NOTED ON THE PURGE HOLE OF GRIPPER WHILE THE EMBOLIC COIL WAS FOUND STRETCHED AND THE SUTURE OF IT WAS FOUND BROKEN; THE EDGES OF THE BROKEN SECTION NOTED ON THE SUTURE APPEARS THAT IT WAS ELONGATED BEFORE IT GOT BROKEN. USING A LAB SAMPLE SYRINGE 635-002, THE ORBIT GALAXY WAS TRIED TO PURGING ON THE BLUE ZONE; AFTER THAT THE PRESSURE GAUGE WAS INCREASED TO THE GREEN ZONE AND THE COIL WAS NOT DETACHED, THE PRESSURE WAS INCREASED TO THE ALTERNATIVE RED ZONE AND THE EMBOLIC COIL WAS DETACHED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 15921686 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE CUSTOMER AS THAT THE COIL DID NOT DETACH WAS NOT CONFIRMED DURING THE FUNCTIONAL TEST. THE FAILURE EXPERIENCED BY THE CUSTOMER AND THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY INSPECTIONS ARE IN PLACE WHICH PREVENT THIS KIND OF FAILURE FROM LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AN ORBIT GALAXY (640CF0824/15921686) COULD NOT BE DEPLOYED WITH A DCS SYRINGE II (635-002/96331215) DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE PATIENT¿S INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY THAT WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. NO REPORTS OF THE ACCOMPANYING DEVICES WERE AVAILABLE. AFTER ANOTHER GALAXY WITH THE SAME LOT # WAS DEPLOYED WITHOUT ANY COMPLICATION INTO THE TARGET ANEURYSM BY USING THE COMPLAINT SYRINGE, THE COMPLAINT COIL WAS INSERTED. THOUGH THE COMPLAINT COIL WAS SUCCESSFULLY PLACED INTO THE ANEURYSM, THE PHYSICIAN WAS UNABLE TO DETACH THE COIL. THE PHYSICIAN ATTEMPTED THE ALTERNATIVE DETACHMENT THRICE, BUT NO AVAIL. THUS, THE BOTH COMPLAINT PRODUCTS WERE REPLACED WITH OTHER PRODUCTS (BOTH LOTS UNKNOWN) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCTS WERE NEW AND 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 PRODUCTS BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE OTHER DEVICES AFTER THE EVENT. THERE WAS NO STRETCHING OF THE COILS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE COMPLAINT PRODUCTS WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661808 ORBIT GALAXY DETACHABLE COIL SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC 640CF0824 15921686

    Patients

    Seq Age Sex Outcome Treatment
    1