BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 2110862 · Received June 2, 2011

    Report

    Report Number
    3007628272-2011-50015
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT IS A DUPLICATE OF MEDWATCH REPORT NO. 3007628272-2011-50016, THEREFORE NOW THIS REPORT WILL BE VOIDED. NO FURTHER INFORMATION WILL BE SUBMITTED FOR THIS REPORT 3007628272-2011-50015.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF THE (ICA) INTERNAL CAROTID ARTERY THE SYRINGE (B)(4) COULD NOT DETACH THE COIL (B)(4) AT THE GREEN ZONE, AND COULD NOT BE DETACHED EVEN WHEN THE ALTERNATIVE DETACHMENT WAS ATTEMPTED. THE SYRINGE WAS CHANGED TO OTHER NEW PRODUCT (SAME CAT/LOT, PI1), BUT THE COIL COULD NOT BE DETACHED. WHEN THE COIL WAS PULLED BACK IN THE MICROCATHETER, IT WAS DETACHED. THE DOCTOR PUSHED THE COIL BY USING THE DELIVERY TUBE. THE DOCTOR COULD INSERT THE COIL INTO TARGET ANEURYSM SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. NO DAMAGES WERE NOTICED ON ANY SECTION OF THE SYRINGE, AND THE SYRINGE WAS CONNECTED PROPERLY WITH EACH DELIVERY SYSTEM HUB. AFTER THE DIFFICULT TO DETACHED, THE SAME SYRINGE WAS NOT UTILIZED WITH OTHER COILS. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE OR DELIVERY SYSTEM. NO FURTHER INFORMATION WAS AVAILABLE. THE VESSEL WAS NOT CALCIFIED OR TORTUOUS.

    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 NA 13500219

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGE