BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GC 8F .088 AL2 100CM

    MDR report key: 237794 · Received August 28, 1999

    Report

    Report Number
    1016427-1999-00149
    Event Type
    Malfunction
    Date Received
    August 28, 1999
    Date of Event
    August 6, 1999
    Report Date
    August 27, 1999
    Manufacturer
    CORDIS CORP (MIAMI)
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PTCA TO THE CIRCUMFLEX OM BRANCH, UPON REMOVAL OF 8 FR AL 2 GC, THE PHYSICIAN NOTICED THAT THE BRITE TIP OF THE CATHETER WAS FRACTURED AND THE BRAIDED WIRE WAS VISIBLE AT THE CATHETER'S END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GC 8F .088 AL2 100CM CARDIOLOGY GUIDING CATHETER DYB CORDIS CORP (MIAMI) NA A0598556

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN