BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY DETACHABLE COIL SYSTEM

    MDR report key: 2873245 · Received December 13, 2012

    Report

    Report Number
    3007628272-2012-50088
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 30, 2012
    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

    THE COIL AND DELIVERY SYSTEM WERE UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 15657707 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS TEST AS PER (EMBOLIC COIL ATTACHMENT PULL TEST (EAS), EMBOLIC COIL DETACHMENT PRESSURE TEST (CDP) AND EMBOLIC HEAD PIECE ATTACHMENT STRENGTH PULL TEST (HAS). THE FINAL ASSEMBLY INSPECTION WAS REVIEWED AND NO ANOMALIES WERE NOTED. BASED ON THE AVAILABLE INFORMATION AND WITHOUT THE RETURN OF THE INVOLVED DEVICE, NO CONCLUSION CAN BE MADE REGARDING THE INABILITY TO INSERT THE ORBIT THROUGH THE UNKNOWN MICROCATHETER. IT IS POSSIBLE THAT PROCEDURAL FACTORS/UNKNOWN MICROCATHETER INTERACTION MAY HAVE CONTRIBUTED AND LED TO THE COIL DETACHMENT. WITH REVIEW OF THE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF ANY RELATED MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, WHILE ADVANCING AN ORBIT GALAXY (640CF0306/15657707) IN AN UNSPECIFIED MICROCATHETER, THE DEVICE WAS ONCE RE-SHEATHED FOR UNKNOWN REASON. THEN, WHEN DURING CAREFULLY REMOVAL OF THE ORBIT GALAXY IN AND OUT, IT WAS NOTICED THAT THE COIL WAS NOT ATTACHED TO THE DELIVERY TUBE ALTHOUGH DETACHMENT WAS NOT ATTEMPTED. IT IS UNKNOWN WHEN AND HOW EXACTLY THIS HAPPENED, BUT THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, BOTH THE ORBIT GALAXY AND THE MICROCATHETER WERE SAFELY REMOVED AS A UNIT FROM THE PATIENT AND WERE REPLACED FOR A NEW ONE (DETAILS UNKNOWN). AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS ALSO UNKNOWN HOW MANY COILS WERE SUCCESSFULLY PLACED DURING THE PROCEDURE. 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. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE ANEURYSM OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE PROCEDURE WAS COIL EMBOLIZATION OF UNSPECIFIED ARTERY ANEURYSM. NO INFORMATION REGARDING THE VESSEL/ANEURYSM WAS PROVIDED. NO PATIENT INFORMATION WAS PROVIDED. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORBIT GALAXY DETACHABLE COIL SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA 15657707

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MICROCATHETER