BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAM SOFT SUPPORT GUIDEWIRE

    MDR report key: 948190 · Received April 16, 2007

    Report

    Report Number
    3003778388-2007-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2007
    Date of Event
    March 16, 2007
    Report Date
    April 13, 2007
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THE GUIDEWIRE TIP REMAINED IN THE PATIENT. THE PHYSICIAN DETERMINED REMOVAL OF THE TIP WAS NOT REQUIRED. WARNING REGARDING THIS ISSUE IS IN IFU.

    Description of Event or Problem · 1

    DURING AN INTERVENTIONAL CORONARY PROCEDURE, THE GUIDEWIRE WAS JAILED BETWEEN A STENT AND THE ARTERY WALL. TO REMOVE THE WIRE, DR HAD TO PULL THE WIRE FIRMLY AND IT BROKE INTO TWO PIECES. SEVEN CMS OF THE WIRE IS STILL IN THE PATIENT'S CORONARY ARTERY. THE NIOBE MAGNEST WERE IN NAVIGATE POSITION WHEN THIS OCCURRED. AFTER DISCUSSION WITH THE HEART SURGEON, THE PHYSICIANS DECIDED TO LEAVE THE REMAINING PIECE IN PLACE AND NOT TAKE THE PATIENT TO SURGERY. THE PATIENT WILL HAVE TO TAKE TICLID FOR REMAINDER OF LIFE TO AVOID THROMBOSIS OF THE STENT. THE DEVICE WAS DISCARDED AT THE HOSPITAL. THE WIRE WAS FROM EITHER LOT P6974865 OR P1985390.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAM SOFT SUPPORT GUIDEWIRE GUIDEWIRE DQO STEREOTAXIS, INC. 001-001514-1 P6974865 OR P1985390

    Patients

    Seq Age Sex Outcome Treatment
    1 YR