BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW .035 FC J3MM 150CM TEF

    MDR report key: 6622502 · Received June 8, 2017

    Report

    Report Number
    1016427-2017-00356
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    May 17, 2017
    Report Date
    July 18, 2017
    Manufacturer
    LAKE REGION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.   PLEASE NOTE THAT ONLY THE COMPLAINT PRODUCT WAS NOT RETURNED FOR INSPECTION AND ONLY THE PACKAGING WAS RECEIVED. 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 INDICATED THAT AFTER OPENING THE PACKAGING FOR THE 150 CM. DGW .035 FC J3 MM. TEF DIAGNOSTIC GUIDEWIRE, SOME YELLOW FOREIGN MATERIAL WAS FOUND. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THE PRODUCT WAS RETURNED FOR INSPECTION, HOWEVER ONLY THE PRODUCT PACKAGING WAS RECEIVED. ADDITIONAL QUESTIONS WERE SENT REGARDING THE PRODUCT RETURN. PICTURES WERE RECEIVED AND ARE ATTACHED TO THE COMPLAINT FILE. THE PRODUCT WAS REPORTED TO NOT BE USED IN THE PATIENT. THERE WAS NO OTHER PRODUCT ISSUE NOTED EITHER AT THE ACCOUNT AFTER THE PROCEDURE OR PRIOR TO SHIPPING FOR INSPECTION. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT PATIENT INJURY. NO TARGET LESION/TARGET LESION CHARACTERISTIC INFORMATION WAS AVAILABLE. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. NO ADDITIONAL INFORMATION IS AVAILABLE.   THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. INSTEAD, A PICTURE OF PRODUCT DGW .035 FC J3MM 150CM TEF WITH CATALOG NUMBER 502521 AND LOT NUMBER 35231332 CONTAINED WITHIN ITS ORIGINAL PACKAGING POUCH WAS RECEIVED. IT IS NOT CLEARLY DEFINE THROUGH THE RECEIVED PICTURE IF THE PACKAGING POUCH IS OPEN OR NOT, SINCE IT CAN BE NOTICED THAT THE PRODUCT (GUIDEWIRE) IS NOT CONTAINED IN THE PROTECTIVE TUBE. THE TWO OTHER PICTURES SHOWED THE PACKAGING POUCH OPENED, AND IT CAN BE OBSERVED THAT A YELLOWISH FOREIGN MATTER WAS LOCATED UNDER THE FLUSHING PORT THAT IS ATTACHED TO THE COILED TUBE DISPENSER. IT WAS NOT POSSIBLE TO DETERMINE THE SIZE OF THE FOREIGN MATTER BY THE RECEIVED PICTURES. ALSO, IT WAS NOTICED ON THESE PICTURES THAT THE PRODUCT (GUIDE WIRE) IS NOT CONTAINED IN THE PROTECTIVE TUBE. NO OTHER ANOMALIES WERE OBSERVED ON THE RECEIVED PICTURES. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE-MENTIONED LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. DURING MANUFACTURING AND PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECTS PRIOR TO SHIPMENT.   THE REPORTED ¿PACKAGING/POUCH/BOX - FOREIGN MATERIAL - IN STERILE PACKAGE¿ COULD NOT BE CONFIRMED SINCE IT COULD NOT BE PROPERLY EVALUATED WITHOUT RETURN OF THE DEVICE AND IT WAS NOT POSSIBLE TO DETERMINE THE ORIGIN/TYPE OF FOREIGN MATTER THROUGH THE RECEIVED PICTURES. THE EXACT CAUSE OF THE ISSUE EXPERIENCED COULD NOT BE DETERMINED DURING ANALYSIS. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE ISSUE REPORT; HOWEVER, STORAGE FACTORS ARE POSSIBLE. ACCORDING TO THE IFU, WHICH IS NOT INTENDED AS A MITIGATION, ¿DO NOT USE IF PACKAGE IS OPEN OR DAMAGED. FLUSH THE GUIDEWIRE WITH STERILE HEPARINIZED NORMAL SALINE OR A SIMILAR ISOTONIC SOLUTION BY CONNECTING A SYRINGE TO THE LUER HUB OF THE GUIDEWIRE DISPENSER.¿ NEITHER THE DHR REVIEW NOR THE PRODUCT PICTURE ANALYSIS SUGGESTS THAT THE FAILURE EXPERIENCED BY THE CUSTOMER IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT AFTER OPENING THE PACKAGING FOR THE 150 CM. DGW .035 FC J3 MM. TEF DIAGNOSTIC GUIDEWIRE, SOME YELLOW FOREIGN MATERIAL WAS FOUND. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WILL BE RETURNED FOR INSPECTION. ADDITIONAL INFORMATION RECEIVED INDICATED THE PRODUCT WAS RETURNED FOR INSPECTION, HOWEVER ONLY THE PRODUCT PACKAGING WAS RECEIVED. ADDITIONAL QUESTIONS WERE SENT REGARDING THE PRODUCT RETURN. PICTURES WERE RECEIVED AND ARE ATTACHED TO THE COMPLAINT FILE. THE PRODUCT WAS REPORTED TO NOT BE USED IN THE PATIENT. THERE WAS NO OTHER PRODUCT ISSUE NOTED EITHER AT THE ACCOUNT AFTER THE PROCEDURE OR PRIOR TO SHIPPING FOR INSPECTION. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT PATIENT INJURY. NO TARGET LESION/TARGET LESION CHARACTERISTIC INFORMATION WAS AVAILABLE. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402831 DGW .035 FC J3MM 150CM TEF WIRE, GUIDE, CATHETER DQX LAKE REGION 502521 35231332

    Patients

    Seq Age Sex Outcome Treatment
    1