BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD DIAGNOSTIC GUIDEWIRES

    MDR report key: 2138353 · Received June 23, 2011

    Report

    Report Number
    1016427-2011-00063
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP OF THE EMERALD DIAGNOSTIC GUIDEWIRE WAS NOTED TO BE KINKED PRIOR TO USE IN THE PATIENT. ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE DISTAL TIP WAS UNRAVELED/STRETCHED. THE ORIGINAL REPORT RECEIVED FROM THE AFFILIATE STATED THAT THE EMERALD DIAGNOSTIC DGW .035 FC J3MM 150CM TEF GUIDE WIRE WAS BROKEN. IT WAS NOTICED BEFORE USED ON PATIENT. WITH FOLLOW-UP INVESTIGATION THE AFFILIATE CONFIRMED THAT THE TIP OF THE WIRE WAS NOT BROKEN BUT KINKED. THE CUSTOMER WAS NOT SURE IF THE WIRE WAS IN THIS CONDITION WHILE IN THE PACKAGING. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THEY NOTED THAT THE WIRE LOOKED NORMAL WHEN TAKEN FROM THE PACKAGING. THERE WAS NO PATIENT INJURY REPORTED. ONE NON STERILE DGW .035 FC J3MM 150CM TEF WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE DISTAL TIP PRESENTED WITH AN UNRAVELED/STRETCHED AND KINKED SECTION OF THE COIL WIRE AT 1 CM TO 2.5 CM FROM DISTAL END. NO OTHER DAMAGES WERE FOUND. THE DAMAGE PRESENTED ON DISTAL TIP WAS CONFIRMED UNDER LIGHT OPTICAL MICROSCOPE. A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE LOT WAS PERFORMED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED KINKED/ BENT FAILURE WAS CONFIRMED IN ADDITION TO A STRETCHED CONDITION. BASED ON THE LIMITED INFORMATION AND REPORT THAT IT APPEARED NORMAL WHEN TAKEN FROM THE PACKAGE, IT APPEARS THAT PROCEDURAL HANDLING MAY HAVE CONTRIBUTED TO THE EVENT. HOWEVER, THE EXACT CAUSE OF THIS DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE EMERALD DIAGNOSTIC GUIDE WIRES MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE ORIGINAL REPORT RECEIVED FROM THE AFFILIATE STATED THAT THE EMERALD DIAGNOSTIC DGW .035 FC J3MM 150CM TEF GUIDE WIRE WAS BROKEN. IT WAS NOTICED BEFORE USED ON PATIENT. ADDITIONAL INFORMATION FOLLOW UP WAS PERFORMED AND THE AFFILIATE CONFIRMED THAT THE TIP OF THE WIRE WAS NOT BROKEN BUT KINKED. THE CUSTOMER WAS NOT SURE IF THE WIRE WAS IN THIS CONDITION WHILE IN THE PACKAGING. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THEY NOTED THAT THE WIRE LOOKED NORMAL WHEN TAKEN FROM THE PACKAGING. THERE WAS NO PATIENT INJURY REPORTED. ANALYSIS WAS PERFORMED ON THE RETURNED PRODUCT AND NOTED THAT THE DISTAL TIP OF THE WIRE WAS UNRAVELED/STRETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERALD DIAGNOSTIC GUIDEWIRES CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F0910886

    Patients

    Seq Age Sex Outcome Treatment
    1