BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    MDR report key: 2802856 · Received October 24, 2012

    Report

    Report Number
    1058196-2012-00396
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 28, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    DQX
    PMA / PMN Number
    K001033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    NOTE: THE AGILITY LOT NUMBER WAS LATER SENT AND PROVIDED. THE CATALOG# IS 614481 AND THE REPORTED LOT# IS 244449 WITH THE MANUFACTURING DATE OF 06/2012 AND EXPIRATION DATE OF 4/18/2014. IT WAS REPORTED THAT BEFORE THE INTERVENTION, THE AGILITY GUIDEWIRE WAS INTRODUCED INTO THE MICROCATHETER AND IT WAS OBSERVED THAT THE TIP OF THE WIRE WAS "LOOSE." IT WAS REPORTED THAT IT OCCURRED PRIOR TO THE INTERVENTION WITH NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. NO FURTHER INFORMATION IS AVAILABLE. IT WAS INDICATED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS; HOWEVER, WITH FURTHER FOLLOW-UP, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND BASED ON THE LIMITED INFORMATION PERTAINING TO THE HANDLING OF THE DEVICE SUCH AS REMOVAL TECHNIQUE OR RE-SHAPING, NO CONCLUSION CAN BE MADE REGARDING THE DAMAGE OR THE ROOT CAUSE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    PER RECEIVED REPORT BEFORE THE INTERVENTION, THE NEURORADIOLOGIST INTRODUCED THE GUIDEWIRE INTO THE MICROCATHETER, AND OBSERVED THAT THE TIP OF THE WIRE WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILITY HYDROPHILIC STEERABLE GUIDEWIRES CES GUIDEWIRES (DQX) DQX CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1