BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOWIRE PTA/PTCA GUIDEWIRE

    MDR report key: 4181199 · Received October 14, 2014

    Report

    Report Number
    2939520-2014-00087
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    NEOMETRICS
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REFERENCE: (B)(4). NEOMETRICS GUIDEWIRE WAS BEING USED WITH PHOENIX ATHERECTOMY DEVICE. NEITHER DEVICE WAS RETURNED TO VOLCANO CORPORATION AS THEY WERE DISCARDED BY THE HOSPITAL. NO FURTHER DEVICE EVALUATION COULD BE PERFORMED. VOLCANO CORPORATION WILL NOTIFY NEOMETRICS OF DEVICE FAILURE.

    Description of Event or Problem · 1

    DURING ATHERECTOMY PROCEDURE OVER AN EXTRA SUPPORT MEDIUM TIP NEOMETRICS GUIDEWIRE, THE PHYSICIAN NOTED EXCESSIVE FRICTION BETWEEN THE GUIDEWIRE AND CATHETER. ATHERECTOMY WAS SUCCESSFULLY COMPLETED AND BRISK FLOW WAS RESTORED TO THE PATIENT 'S DISTAL VESSEL. HOWEVER, UPON REMOVAL, THE DISTAL TIP OF THE GUIDEWIRE WHICH IS APPROXIMATELY 2-3MM IN LENGTH BROKE OFF AND WAS LEFT IN INSIDE THE PATIENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649050 NEOWIRE PTA/PTCA GUIDEWIRE GUIDEWIRE DQX NEOMETRICS OFG1953FE MO26873

    Patients

    Seq Age Sex Outcome Treatment
    1