BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD DIAGNOSTIC GUIDEWIRES

    MDR report key: 1170702 · Received September 16, 2008

    Report

    Report Number
    1016427-2008-00244
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, AS OF TO DATE, THE EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A PULMONARY ARTERY ANGIOGRAPHIC, THE EMERALD WIRE WAS ADVANCED TO THE PATIENT FOR ABOUT 140CM. THE PHYSICIAN FOUND THE GREEN COATING OF THE EMERALD GUIDE WIRE FELL OFF 40CM NEAR THE TIP. THE PART OF GUIDE WIRE INSIDE THE CATHETER WAS NOT SMOOTH. AFTER IDENTIFYING THE PROBLEM, THE PHYSICIAN TRIED TO WITHDRAW THE GUIDE WIRE, BUT FAILED. THEREFORE THE GUIDE WIRE AND THE CATHETER WERE REMOVED AS A UNIT. THE PHYSICIAN EXCHANGED THE WIRE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY INJURY TO THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERALD DIAGNOSTIC GUIDEWIRES ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION NA F0907731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK