BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 1071662 · Received July 7, 2008

    Report

    Report Number
    9616099-2008-01678
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 9, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE MOLDING TIP PARAMETERS AND THE FPI/LPI RESULTS WERE ACCEPTED ACCORDING THE SPECIFICATION. BASED ON THE LIMITED INFORMATION AND WITHOUT THE RETURN OF THE PRODUCT FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE INSERTION DIFFICULTY AND DAMAGE NOTED ON REMOVAL OF THE BRITETIP SHEATH INTRODUCER. IT IS POSSIBLE THAT PROCEDURAL FACTORS AND VESSEL CHARACTERISTICS CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT RESISTANCE WAS FELT DURING INSERTION OF THE BRITETIP SHEATH INTRODUCER. THE SHEATH WAS WITHDRAWN AND THE MARKER OF THE SHEATH WAS PARTIALLY JAGGED. ANOTHER UNKNOWN PRODUCT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE TARGET LESION/VESSEL CHARACTERISTICS ARE NOT KNOWN. THERE WAS NO REPORT OF ANY PRE-USE INSPECTION ANOMALIES AND THERE IS NOT FURTHER INFORMATION. THERE WAS NO ADVERSE EVENT TO THE 70-YEAR-OLD PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI BRITE TIP ENDOVASCULAR VASULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 13291669

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR