BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 1031409 · Received April 18, 2008

    Report

    Report Number
    9616099-2008-01026
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 24, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REMOVING A 6F VISTA BRITE TIP GUIDE CATHETER FROM ITS PACKAGE, THE CATHETER WAS FOUND "FRACTURED". THE PRODUCT WAS NOT USED AND NO PT INJURY OCCURRED. MULTIPLE ATTEMPTS TO OBTAIN CLARIFICATION AND ADD'L DETAILS WERE UNSUCCESSFUL. THE PRODUCT WAS NOT RETURNED FOR EVAL. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. WITHOUT RETURN OF THE PRODUCT, THE COMPLAINT COULD NOT BE CONFIRMED. IN THE ABSENCE OF ANY ADD'L INFO, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    WHEN THE PACKAGE OF A 6F, XB3.5 VISTA BRITE TIP GUIDING CATHETER WAS OPENED, AND THE PRODUCT WAS REMOVED, IT WAS OBSERVED THAT THE CATHETER WAS FRACTURED. THEREFORE, THE PRODUCT COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 13278571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA