BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIZDOM SGW

    MDR report key: 3970215 · Received July 31, 2014

    Report

    Report Number
    1016427-2014-00091
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K953760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THE 180 CM. SGW WIZDOM ST FLOPPY ST GUIDEWIRE WAS SEPARATED DURING USE IN THE PATIENT. THE EVENT OCCURRED WHILE OBTAINING VASCULAR ACCESS. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). PRELIMINARY INSPECTION OF THE RETUNED PRODUCT INDICATED THAT THE DISTAL END OF THE DEVICE WAS DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER NO OTHER DETAILS HAVE BEEN PROVIDED. A NON-STERILE UNIT OF SGW .014 WIZ ST FLOPPY 180 ST WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. A KINK CONDITION WAS FOUND AT 7 CM FROM DISTAL TIP END. ADDITIONALLY A COATING DELAMINATING CONDITION ON GUIDEWIRE WAS FOUND AT 1.5 CM. NO OTHER ANOMALIES WERE FOUND. COATING DELAMINATING WAS ANALYZED UNDER VISION SYSTEM AND IT CAN BE OBSERVED THAT THE COATING PRESENTED ELONGATION ACCORDIONED CONDITIONS ON THE GUIDEWIRE. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10346516. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED ¿GUIDEWIRE / FRACTURED-SEPARATED/IN PATIENT¿ WAS NOT CONFIRMED SINCE THE PRODUCT WAS NOT RECEIVED FRACTURED OR SEPARATED FOR ANALYSIS. HOWEVER, THE DEVICE WAS NOTED TO BE KINKED AND THE COATING DELAMINATED. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. ELONGATION AND ACCORDIONED CONDITION OF THE RETURNED DEVICE MAY SUGGEST THAT HANDLING FACTORS DURING REMOVAL FROM THE PACKAGE MAY HAVE CONTRIBUTED TO THIS CONDITION. NEITHER THE ANALYSIS NOR THE INFORMATION AVAILABLE SUGGEST THAT THE ISSUE COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THE 180 CM. SGW WIZDOM ST FLOPPY ST GUIDEWIRE WAS SEPARATED DURING USE ON THE PATIENT. THE EVENT OCCURRED WHILE OBTAINING VASCULAR ACCESS. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). PRELIMINARY INSPECTION OF THE RETUNED PRODUCT INDICATED THAT THE DISTAL END OF THE DEVICE WAS DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER DETAILS WERE PROVIDED AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447222 WIZDOM SGW CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 35220581

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening