BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NINJA FAX BALLOON

    MDR report key: 331603 · Received May 7, 2001

    Report

    Report Number
    1016427-2001-00113
    Event Type
    Malfunction
    Date Received
    May 7, 2001
    Date of Event
    April 9, 2001
    Report Date
    May 7, 2001
    Manufacturer
    CORDIS CORP. (MIAMI)
    Product Code
    LOX
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BALLOON RUPTURED AT 8 ATMOSPHERES WITHIN A CALCIFIED LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20908 NINJA FAX BALLOON PTCA BALLOON CATHETERS LOX CORDIS CORP. (MIAMI) NA 40800693

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN