BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 1852522 · Received October 4, 2010

    Report

    Report Number
    3007628272-2010-50003
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS TREATMENT OF A 3.5X6MM RUPTURED ANEURYSM AT THE ANTERIOR CHOROIDAL ORIGIN WHICH WAS DETERMINED TO BE TOO RISKY FOR CLIPPING. THE FIRST COIL, A 4MMX10CM COMPLEX XTRASOFT ORBIT GALAXY COIL (640CX0410 /13500036) WAS SEEN PROTRUDING INTO THE RIGHT M1 IN AN UNEXPECTED DELAYED FASHION AFTER DETACHMENT. IT WAS NOT TUCKED IN THE ANEURYSM. TWO ADDITIONAL COILS WERE PLACED USING BALLOON REMODELING WITHOUT FURTHER INCIDENT. THE COIL MASS WAS STABLE ON REPEAT ANGIOGRAPHY SO IT WAS DECIDED NOT TO RETRIEVE THE COIL. IT WAS REPORTED THAT PRIOR TO DETACHMENT OF THE COIL THE POSITION OF THE COIL WAS VERIFIED WITH FLUOROSCOPY AND WAS IN GOOD POSITION, FULLY WITHIN THE ANEURYSM. THERE WERE NO ISSUES POSITIONING THE COIL IN THE ANEURYSM OR DURING DETACHMENT. HOWEVER, CONSTANT FLUOROSCOPY WAS NOT CONDUCTED UNTIL AFTER THE COIL WAS DETACHED. NO ADDITIONAL MANIPULATION OCCURRED DURING DETACHMENT, AND THE COIL DELIVERY SYSTEM DID NOT MOVE DURING THE EVENT. THE SYRINGE LOST PRESSURE AFTER THE COIL DETACHED. NO ADDITIONAL PROCEDURES WERE PERFORMED DURING THE EVENT. TWO ADDITIONAL COILS (4MM X 6CM AND 2.5MMX5CM COMPLEX XTRASOFT GALAXY) WERE THEN PLACED WITH BALLOON REMODELING (5X20 HYPERGLIDE/XPEDION). THE SAME SYRINGE WAS USED WITH THESE COILS. ALL LABELING INSTRUCTIONS WERE FOLLOWED FOR FILLING THE SYRINGE AND DETACHMENT OF THE COIL WITH THE SYRINGE. THERE WAS NO RESIDUAL FILING OF THE ANEURYSM OR CHANGE IN POSITION OF COIL LOOPS AT THE END OF THE STUDY OR 12 MINUTES LATER. IN ADDITION, A 6.5 FR. SHEATH WAS USED ALONG WITH A PROWLER 14-90 AND A NEUROSCOUT GUIDEWIRE WERE USED DURING THE PROCEDURE. THE COIL REMAINS IMPLANTED AND THE DELIVERY SYSTEM IS NOT AVAILABLE FOR ANALYSIS. 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. REVIEW OF LOT 13500036 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION TEST RESULTS. PREVENTIVE MAINTENANCE RECORDS FOR COIL LOADING MACHINE WERE REVIEWED, AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCE WAS EXECUTED DURING THE ESTABLISHED TIME PERIOD. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE PREVENTIVE MAINTENANCE DATES. NO CONCLUSION CAN BE MADE REGARDING THE PROTRUSION OF THE ORBIT GALAXY COIL OUT OF THE ANEURYSM AFTER DEPLOYMENT. BASED ON THE REPORT THAT A BALLOON REMODELING TECHNIQUE WAS USED FOR PLACEMENT OF SUBSEQUENT COILS, IT IS POSSIBLE THAT VESSEL AND ANEURYSM CHARACTERISTICS CONTRIBUTED TO THE EVENT. WITH REVIEW OF THE DEVICE HISTORY RECORDS, THERE ARE NO IDENTIFIED MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THERE WAS NO RESIDUAL FILING OF THE ANEURYSM OR CHANGE IN POSITION OF COIL LOOPS AT THE END OF THE STUDY AND 12 MINUTES LATER. A 6.5 FR. SHEATH WAS USED ALONG WITH A PROWLER 14-90, A NEUROSCOUT GUIDEWIRE, 5X20 HYPERGLIDE/XPEDION AND 4XXM10CM, 4MM X 6CM AND 2.5MMX5CM COMPLEX XTRASOFT GALAXY COILS THERE WERE NO ISSUES POSITIONING THE COIL IN THE ANEURYSM OR DURING DETACHMENT, OR ENTANGLEMENT WITH THE FIRST COIL. HOWEVER, CONSTANT FLUOROSCOPY WAS NOT CONDUCTED UNTIL AFTER THE COIL WAS DETACHED. NO ADDITIONAL MANIPULATION OCCURRED DURING DETACHMENT, AND THE COIL DELIVERY SYSTEM DID NOT MOVE DURING THE EVENT. THE SYRINGE LOSS PRESSURE AFTER THE COIL DETACHED. NO ADDITIONAL PROCEDURES WERE PERFORMED DURING THE EVENT. ALL LABELING INSTRUCTIONS WERE FOLLOWED FOR FILLING THE SYRINGE AND DETACHMENT OF THE COIL WITH THE SYRINGE. THE SAME SYRINGE WAS UTILIZED WITH OTHER PRODUCTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TREATMENT OF A 3.5X6MM RUPTURED ANEURYSM AT THE ANTERIOR CHOROIDAL ORIGIN WHICH WAS DETERMINED TO BE TOO RISKY FOR CLIPPING. THE FIRST COIL, A 4MMX10CM COMPLEX XTRASOFT ORBIT GALAXY COIL (640CX0410 /(B)(4)) WAS SEEN TO PROTRUDE INTO THE RIGHT M1 IN AN UNEXPECTED DELAYED FASHION AFTER DETACHMENT. ADDITIONAL COILS WERE PLACED WITHOUT FURTHER INCIDENT. IT WAS REPORTED THAT PRIOR TO DETACHMENT OF THE COIL THE POSITION OF THE COIL WAS VERIFIED WITH FLUOROSCOPY AND WAS IN GOOD POSITION, FULLY WITHIN THE ANEURYSM. THE COIL MASS WAS STABLE ON REPEAT ANGIOGRAPHY SO, IT WAS DECIDED NOT TO RETRIEVE THE COIL. TWO ADDITIONAL COILS WERE THEN PLACED WITH BALLOON REMODELING, AND WITH THE SAME SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC 13500036

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening