BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDWIRE PLUS 200CM J

    MDR report key: 485242 · Received September 15, 2003

    Report

    Report Number
    1220452-2003-00127
    Event Type
    Malfunction
    Date Received
    September 15, 2003
    Date of Event
    September 1, 2003
    Report Date
    September 8, 2003
    Manufacturer
    MEDTRONIC VASCULAR
    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, DURING THE PTCA THE OCCLUSION BALLOON RUPTURED WHEN THE PHYSICIAN ATTEMPTED TO INFLATE TO 5-6MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE PLUS 200CM J DISTAL PROTECTION DEVICES NFA MEDTRONIC VASCULAR NA 138005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA