BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE PLUS 200CM J

    MDR report key: 485243 · Received September 15, 2003

    Report

    Report Number
    1220452-2003-00128
    Event Type
    Malfunction
    Date Received
    September 15, 2003
    Date of Event
    September 5, 2003
    Report Date
    September 11, 2003
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    NFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE PTCA, THE PHYSICIAN INFLATED THE OCCLUSION BALLOON BUT IT DEFLATED ITSELF IMMEDIATELY. AFTER HE REMOVED THE GUARD WIRE FROM THE PATIENT, HE INFLATED IT AND NOTICED A LEAK FROM INFLATION HOLE OF THE GUARDWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE PLUS 200CM J DISTAL PROTECTION DEVICES NFA MEDTRONIC VASCULAR NA 128417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA