BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 1893808 · Received November 9, 2010

    Report

    Report Number
    9616099-2010-00854
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 15, 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 RESISTANCE/FRICTION WAS ENCOUNTERED WHILE ATTEMPTING TO INSERT THE BRITE TIP SHEATH. AFTER SEVERAL ATTEMPTS WERE MADE TO PUSH THE SHEATH, THE DISTAL END WAS FOUND TO BE FRAYED. THE ACCESS SITE IS UNKNOWN, RESISTANCE WAS FELT WITH THE SKIN, AND A RADIO FOCUS TERUMO GUIDEWIRE WAS USED. THE USE OF A TERUMO WIRE TYPICALLY INDICATES THAT THERE IS DIFFICULTY ACCESS THE ARTERIOTOMY WITH THE WIRES THAT ARE PROVIDED WITH THE SHEATH TO HELP GAIN ACCESS. THE DIFFICULTY ENCOUNTERED MAY BE DUE TO CALCIFICATION OR TORTUOUSITY, NEITHER OF THESE CHARACTERISTICS IS KNOWN. THE PATIENT HAD A HEPATIC LESION. THEREFORE, THE DEVICE WAS EXCHANGED TO A NEW PRODUCT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS NO PATIENT INJURY REPORTED. 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 COULD NOT BE CONFIRMED. CONTINUED ATTEMPTS TO ADVANCE A SHEATH AGAINST RESISTANCE CAN LEAD TO THE DISTAL TIP BECOMING FRAYED. REVIEW OF THE LIMITED INFORMATION PROVIDED SUGGESTS THAT THERE MAY HAVE BEEN VESSEL/LESION CHARACTERISTICS THAT MAY 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

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT HAD A HEPATIC LESION. RESISTANCE/FRICTION WAS FELT WHILE INSERTING THE BRITE TIP SHEATH INTRODUCER, TOGETHER WITH THE DILATOR, INTO THE PATIENT. AFTER SEVERAL ATTEMPTS WERE MADE TO PUSH THE SHEATH, THE DISTAL END OF THE SHEATH WAS FOUND FRAYED. THEREFORE, THE DEVICE WAS EXCHANGED TO A NEW PRODUCT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 15029240

    Patients

    Seq Age Sex Outcome Treatment
    1