BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 3132207 · Received May 29, 2013

    Report

    Report Number
    1226348-2013-10027
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 20, 2013
    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 DEVICE IS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 15705224 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS (EMBOLIC COIL ATTACHMENT PULL TEST AND EMBOLIC COIL DETACHMENT PRESSURE) AND THE RESULT WERE ACCEPTED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING POSSIBLE ROOT CAUSE. VIA THE RISK MANAGEMENT PROCESS AN INVESTIGATION HAS BEEN OPENED TO FURTHER INVESTIGATE AND ADDRESS COMPLAINTS OF DETACHMENT DIFFICULTIES ASSOCIATED WITH THE ORBIT GALAXY. ACTION WAS OPENED TO ADDRESS GALAXY FAILURE TO DETACH COMPLAINTS.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION PROCEDURE OF AN UNSPECIFIED ARTERY ANEURYSM, AN ORBIT GALAXY COIL (640CX0306/15705224) WOULD NOT DETACH AT THE GREEN ZONE USING THE DCS SYRINGE II (635-002, LOT UNKNOWN). IT IS UNKNOWN IF AN ATTEMPT MADE TO DETACH THE COIL AT THE RED ALTERNATIVE DETACHMENT ZONE. THEN, THE ORBIT GALAXY WAS SAFELY REMOVED FROM THE PATIENT. AFTER THAT, THE ORBIT GALAXY COIL WAS REPLACED FOR A NEW PRODUCT (640CX0306, LOT UNKNOWN) THAT WAS DETACHED WITHOUT ANY PROBLEM. HOWEVER, IT WAS UNKNOWN IF THE SAME SYRINGE WAS USED WITH THE NEXT COIL. 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. A DEDICATED SALINE SOURCE WAS USED TO FILL THE SYRINGE. 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 (BRAND NAME AND TYPE UNKNOWN). AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THE VESSEL WAS NOT CALCIFIED AND MILDLY TORTUOUS. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235223 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA 15705224

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGE II