BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE PLUS 200CM J

    MDR report key: 484214 · Received September 10, 2003

    Report

    Report Number
    1220452-2003-00125
    Event Type
    Malfunction
    Date Received
    September 10, 2003
    Date of Event
    September 2, 2003
    Report Date
    September 5, 2003
    Manufacturer
    MEDTRONIC VASCULAR, INC.
    Product Code
    NFA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE PHYSICIAN ADVANCED A GUIDANT UNICORE GUIDE WIRE TO A SEVERE LESION. HE THEN TRIED TO PASS AN OCCLUSION BALLOON BUT IT WOULD NOT PASS THROUGH THE LESION. HE ALTERNATED WITH ANOTHER PHYSICIAN BUT HE WAS ALSO UNABLE TO PASS THE OCCLUSION DEVICE. DURING THE SECOND ATTEMPT TO PASS, THE WIRE BROKE INTO TWO PIECES. THE PROXIMAL SEGMENT WAS EASILY REMOVED, THE DISTAL SEGMENT WAS REMOVED USING A SNARE. THE PTCA WAS COMPLETED WITHOUT THE USE OF AN OCCLUSION DEVICE. THE PHYSICIANS SAID THAT THEY NEVER APPLIED STRONG FORCE WHILE THEY WERE TRYING TO PASS THE OCCLUSION DEVICE THROUGH THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE PLUS 200CM J DISTAL PROTECTION DEVICES NFA MEDTRONIC VASCULAR, INC. NA 135198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA