BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSENCE STEERABLE GUIDEWIRES

    MDR report key: 3884299 · Received June 19, 2014

    Report

    Report Number
    1058196-2014-00179
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    DQX
    PMA / PMN Number
    K955637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE THE SURGEON FELT FRICTION WHEN HE ADVANCED THE SGW ESSENC .014/.012 175 ST SS (612348/15691431) TO THE DISTAL PART OF THE VESSEL. THE SURGEON REMOVED THE WIRE AND NOTED IT WAS STRETCHED IN THE TIP. CHANGED TO ANOTHER WIRE (DETAILS UNKNOWN) TO COMPLETE. NO ADVERSE EVENT OCCURRED. THE PRODUCT WAS NOT RESTERILIZED. THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. IT IS UNKNOWN IF THE WIRE WAS RE-SHAPED BY THE USER. THE WIRE WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. THE WIRE WAS NOT TORQUED AGAINST RESISTANCE. IT IS UNKNOWN IF THE LESION WAS A CHRONIC TOTAL OCCLUSION (100% OCCLUSION FOR > 3 MONTHS). THE WIRE TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THE TARGET VESSEL WAS NOT PROVIDED. THE VESSEL WAS NOT CALCIFIED AND NOT TORTUOUS. ONE NON STERILE SGW ESSENC .014/.012 175 ST SS GUIDEWIRE WAS RECEIVED COILED INSIDE A PLASTIC BAG. A KINK WAS OBSERVED AT 2CM FROM PROXIMAL END; THE COILED DISTAL TIP WAS OBSERVED BENT AND UNRAVELED/STRETCHED. NO OTHER VISUAL ANOMALIES WERE FOUND IN THE UNIT RECEIVED. THE GUIDEWIRE WAS OBSERVED UNDER MICROSCOPE AND NO ANOMALIES RATHER THAN THE VISUALLY OBSERVED WERE FOUND. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10150980. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE REPORTED BY THE CUSTOMER AS ¿GUIDE WIRE - RESISTANCE/FRICTION¿ COULD NOT BE EVALUATED DUE TO NATURE OF THE COMPLAINT. THE FAILURE ¿DISTAL TIP - UNRAVELED/STRETCHED-IN PATIENT¿ REPORTED BY THE CUSTOMER WAS CONFIRMED. THE EXACT CAUSE OF THE REPORTED EVENTS AS WELL AS KINKS AND BENTS OBSERVED DURING THE ANALYSIS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER AS PER EVENT DESCRIPTION AND ANALYSIS OF THE PRODUCTS, PROCEDURAL FACTORS MIGHT HAVE CONTRIBUTED TO MENTIONED FAILURES. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALY THAT COULD BE CONTRIBUTED TO THE EVENTS AS REPORTED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE SURGEON FELT FRICTION WHEN HE ADVANCED THE SGW ESSENC .014/.012 175 ST SS (612348/15691431) TO THE DISTAL PART OF THE VESSEL. THE SURGEON REMOVED THE WIRE AND NOTED IT WAS STRETCHED IN THE TIP. CHANGED TO ANOTHER WIRE (DETAILS UNKNOWN) TO COMPLETE. NO ADVERSE EVENT OCCURRED. NO VESSEL CODE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359889 ESSENCE STEERABLE GUIDEWIRES CES GUIDEWIRES (DQX) DQX CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NEW WIRE (DETAILS UNKNOWN)