BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 1893912 · Received November 9, 2010

    Report

    Report Number
    9616099-2010-00856
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    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

    INFORMATION RECEIVED FROM AN AFFILIATE INDICATED THAT DURING INSERTION OF A 7FR BRITE TIP SHEATH RESISTANCE/FRICTION OCCURRED, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT THE DISTAL TIP WAS NOTED TO BE FRAYED. THE PROCEDURE WAS STARTED WITH A 4FR SHEATH THAT WAS INSERTED WITHOUT DIFFICULTY AND THE RESISTANCE/FRICTION OCCURRED DURING EXCHANGE OF THE TWO SHEATHS. THE TARGET LESION WAS SUPERIOR MESENTERIC ARTERY. ANOTHER NEW BRITE TIP SHEATH OF THE SAME SIZE WAS USED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE IS NO INFORMATION REGARDING VESSEL/LESION CHARACTERISTICS OF THE ACCESS SITE ARTERY. THERE WAS NO REPORT OF PATIENT INJURY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITHOUT THE RETURN OF THE DEVICE THE REPORTED CUSTOMER COMPLAINT OF FRAYED TIP COULD NOT BE CONFIRMED. RESISTANCE/FRICTION COULD NOT BE CONFIRMED EITHER. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO MAKE AN EDUCATED ASSESSMENT FOR THE REPORTED EVENT, BUT THERE IS THE POSSIBILITY THAT VESSEL CHARACTERISTICS COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A PTA PROCEDURE, FRICTION WAS EXPERIENCED AS THE BRITE TIP SHEATH WAS INSERTED INTO THE RIGHT FEMORAL ARTERY OF THE PATIENT. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE DISTAL TIP WAS FOUND TO BE FRAYED. ANOTHER NEW BRITE TIP SHEATH OF THE SAME SIZE WAS USED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 15104989

    Patients

    Seq Age Sex Outcome Treatment
    1