BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT FIXED CORE WIRE GUIDE

    MDR report key: 7126460 · Received December 18, 2017

    Report

    Report Number
    1820334-2017-04340
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 18, 2017
    Manufacturer
    COOK INC
    Product Code
    DXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. EVALUATION / INVESTIGATION A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED. A REVIEW OF DRAWINGS, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA AND SPECIFICATIONS WAS ALSO PERFORMED. THE C-SF-15-50 STRAIGHT FIXED CORE WIRE GUIDE HAVING AN UNKNOWN LOT NUMBER WAS RETURNED IN A USED AND DAMAGED CONDITION. A VISUAL EXAMINATION NOTED THE WIRE WAS RECEIVED IN TWO SECTIONS. THE SECTION HAVING THE FLEXIBLE TIP MEASURED APPROXIMATELY 20CM IN ITS CURRENT CONDITION. THE WELD BALL WAS PRESENT AND ATTACHED TO THE COIL. THE REMAINING PORTION OF THE GUIDE MEASURED IN ITS CURRENT STATE INCLUDING COIL ELONGATION AT APPROXIMATELY 84.5CM IN LENGTH. THE PROXIMAL WELD WAS PRESENT AND ATTACHED TO THE MANDRIL WIRE AND COIL. THE OUTER DIAMETER (OD) OF THE COIL HAD A MEASUREMENT OF 0.0155 INCHES. BASED ON THE CONDITION OF THE RETURNED WIRE, A DETERMINATION THAT THE ENTIRE WIRE WAS RETUNED CANNOT BE MADE. THE DEVICE FAILURE ANALYSIS CONFIRMED ALL OF THE REPORTED EVENT FAILURES DID OCCUR. IT IS REASONABLE TO SUGGEST THE WIRE GUIDE KINKED UPON ADVANCEMENT OR THE PHYSICIAN¿S INITIAL ATTEMPT TO WITHDRAW IT. PATIENT ANATOMY COULD HAVE ALSO ATTRIBUTED TO THIS FAILURE. ALTHOUGH THE CORRECT MANUFACTURING DOCUMENTS ARE IN PLACE, BECAUSE THE LOT NUMBER WAS NOT ABLE TO BE PROVIDED, IT COULD NOT BE CONFIRMED WHETHER THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY; DEVICE INTEGRITY PRIOR TO SHIPPING. BASED ON THE INFORMATION ABOVE, A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED OR REPORTED AT THIS TIME. THE RISK WAS ASSESSED BASED ON THE CURRENT RISK DOCUMENTATION, REVEALING THAT NO OTHER RISK MITIGATING ACTIVITIES ARE NECESSARY AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE PROPER PERSONNEL ABOUT THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIALOENDOSCOPY PROCEDURE THE WIRE GUIDE BECAME KINKED WITHIN THE SCOPE, MAKING IT DIFFICULT TO REMOVE. THE WIRE GUIDE WAS PULLED FORCEFULLY, CAUSING IT TO UNCOIL AND BREAK. THE WIRE GUIDE WAS OUTSIDE THE PATIENT WHEN IT BROKE. THE SCOPE HAD BEEN REMOVED FROM THE PATIENT AND THE WIRE GUIDE WAS IN THE WORKING CHANNEL OF THE SCOPE. THERE WAS NO ADVERSE EFFECTS TO THE PATIENT FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904973 STRAIGHT FIXED CORE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1