BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGFW.035 FC J3MM SS 150CM PTFE

    MDR report key: 792816 · Received November 28, 2006

    Report

    Report Number
    1016427-2006-00115
    Event Type
    Malfunction
    Date Received
    November 28, 2006
    Date of Event
    November 3, 2006
    Report Date
    November 28, 2006
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MKI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE TRYING TO RETRIEVE THE WIRE AFTER A DIAGNOSTIC PROCEDURE IN THE ILIAC ARTERY, THE WIRE WAS NOTED TO BE DAMAGED. IT WAS DISENTANGLED (UNTWISTED) IN THE DISTAL PART. THERE IS NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE, IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE HAD AN IMPACT ON THIS EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. WITHOUT RETURN OF THE ACTUAL PRODUCT IN QUESTION FOR EVALUATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MFG, INSPECTING AND PACKAGING OF THE INVOLVED LOT INDICATES THAT THE PRODUCT WAS FINAL INSPECTION TESTED AND DETERMINED TO BE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DGFW.035 FC J3MM SS 150CM PTFE ENDOVASCULAR WIRES & METALS MKI CORDIS CORPORATION NA N0406156

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN