BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 4770916 · Received May 14, 2015

    Report

    Report Number
    3008264254-2015-00030
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 22, 2015
    Report Date
    May 22, 2015
    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

    COMPLAINT CONCLUSION:DURING COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY ANEURYSM, IT WAS REPORTED THAT WHEN ADVANCING THE ORBIT GALAXY (640CF0410 / 15954486), THE PHYSICIAN EXPERIENCED A SEVERE RESISTANCE AT THE MIDDLE OF THE UNSPECIFIED MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RECOVER THE COIL, BUT WHILE BEING WITHDRAWN, THE EMBOLIC COIL PREMATURELY DETACHED IN THE MICROCATHETER, AFTER IT WAS PARTLY OUT OF THE MICROCATHETER, AND WAS THEN REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES, BUT DUE TO THE EVENT, THE PROCEDURE WAS DELAYED FOR 40 MINUTES. NEVERTHELESS, THE DELAY WAS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT AS THERE WERE NO PATIENT INJURY/COMPLICATIONS. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. NO VISIBLE DAMAGE WAS NOTED ON THE PRODUCT PRIOR TO THE EVENT. NO FURTHER INFORMATION WAS AVAILABLE.A NON-STERILE ORBIT GALAXY TDL COMPLEX FILL COIL 4X10 WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS FOUND KINKED. THE INTRODUCER WAS FOUND PARTIALLY ZIPPED AND IT WAS FOUND ELONGATED. THE SUPPORT COIL WAS FOUND WITHOUT DAMAGE. THE GRIPPER WAS FOUND OUTSIDE OF THE INTRODUCER WHILE THE EMBOLIC COIL WAS NOT RETURNED FOR EVALUATION. THE GRIPPER WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND WITH WAVE CONDITION, BUT NO OBSTRUCTIONS OR DAMAGES WERE NOTED ON THE PURGE HOLE. MARKS SHOWING THE EMBOLIC COIL WAS ATTACHED TO THE GRIPPER COULD BE OBSERVED. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE FUNCTIONAL TEST CANNOT BE PERFORMED SINCE THE INTRODUCER WAS FOUND ELONGATED. THE REVIEW OF LOT 15954486 REVEALED THAT (B)(4) UNIT WAS DEFECT FOR ¿DAMAGED HEADPIECE¿, AND IT COULD BE RELATED TO THE REPORTED COMPLAINT. HOWEVER, THE DHR REVIEW CONFIRMED THAT THE REJECTED UNIT WAS PROPERLY SEGREGATED AND DISCARDED. CONTROLS ARE IN PLACE TO DETECT SUCH NONCONFORMITIES. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT.THE FAILURE REPORTED BY THE COSTUMER AS PREMATURE DETACHMENT COULD NOT BE EVALUATED SINCE THE COIL WAS NOT RETURNED FOR ANALYSIS. THE DAMAGES FOUND ON THE GRIPPER (WAVE¿S CONDITION) APPARENTLY CAN OCCUR DURING THE HANDLING OF THE UNIT. THE REPORTED RESISTANCE COULD NOT BE EVALUATED SINCE THE INTRODUCER WAS FOUND ELONGATED. ALTHOUGH THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED, RESISTANCE WITHIN THE MICROCATHETER MAY HAVE CONTRIBUTED TO THE ELONGATION OF THE INTRODUCER AND THE PREMATURE DETACHMENT. THE IFU CAUTIONS ¿NEVER ADVANCE, WITHDRAW, OR TORQUE THE DELIVERY TUBE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. MANIPULATION OF THE DELIVERY TUBE AGAINST RESISTANCE CAN CAUSE DAMAGE AND/OR PREMATURE DETACHMENT OF THE COIL. IF UNUSUAL FRICTION IS NOTED WITHIN THE INFUSION CATHETER, REMOVE THE DETACHABLE COIL SYSTEM.¿ NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS; ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE MANUFACTURING FACILITY. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY ANEURYSM, IT WAS REPORTED THAT WHEN ADVANCING THE ORBIT GALAXY (640CF0410 / 15954486), THE PHYSICIAN EXPERIENCED A SEVERE RESISTANCE AT THE MIDDLE OF THE UNSPECIFIED MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RECOVER THE COIL, BUT WHILE BEING WITHDRAWN, THE EMBOLIC COIL PREMATURELY DETACHED IN THE MICROCATHETER, AFTER IT WAS PARTLY OUT OF THE MICROCATHETER, AND WAS THEN REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES, BUT DUE TO THE EVENT THE PROCEDURE WAS DELAYED FOR 40 MINUTES. NEVERTHELESS, THE DELAY WAS NOT CLINICALLY SIGNIFICANT AS THERE WERE NO PATIENT INJURY/COMPLICATIONS. THE COMPLAINT PRODUCT WAS 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. NO VISIBLE DAMAGE WAS NOTED ON THE PRODUCT PRIOR TO THE EVENT. THE COMPLAINT PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317342 ORBIT GALAXY DETACHABLE COIL SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC 15954486

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED MICROCATHETER