BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 1872273 · Received October 18, 2010

    Report

    Report Number
    9616099-2010-00801
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEJAVU GUIDEWIRE WAS USED DURING THE INDEX PROCEDURE. A VISTA BRITE TIP GUIDING CATHETER WAS DELIVERED TO THE OSTIUM OF THE LEFT RENAL ARTERY. A GUIDEWIRE CROSSED THE LESION. FRICTION WAS FELT WHILE ADVANCING THE IVUS CATHETER IN THE GUIDING CATHETER; THEREFORE, THE CATHETER, WIRE AND IVUS CATHETER WERE WITHDRAWN. AFTER THE GUIDING CATHETER WAS REMOVED FROM THE PATIENT, "A PART OF THE COATING CAME OUT FROM THE CATHETER WHEN FLUSHED THE GUIDEWIRE LUMEN". THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDING CATHETER AND THERE WAS NO PATIENT INJURY. ATTEMPTS TO DETERMINE WHAT IVUS SYSTEM WAS USED WERE UNSUCCESSFUL. ONE NON-STERILE 6FR VISTA BRITE TIP GUIDE CATHETER WAS RETURNED FOR ANALYSIS. THE CATHETER WAS KINKED AT 46.9 CM FROM THE BRITE TIP. NO OTHER ANOMALIES WERE FOUND. FOR FUNCTIONAL ANALYSIS, A LAB SAMPLE 0.038 GUIDEWIRE WAS INSERTED THROUGH THE CATHETER AND NO RESISTANCE/FRICTION WAS FELT. THE INNER DIAMETER OF THE CATHETER WAS MEASURED AGAINST THE APPROPRIATE DRAWING AT DIFFERENT SECTIONS AND THE INNER DIAMETER WAS WITHIN SPECIFICATION. AFTER THE FUNCTIONAL AND DIMENSIONAL ANALYSIS, THE CATHETER WAS CUT OPEN TO CHECK THE COATING; NO DAMAGES WERE OBSERVED THROUGH THE INNER LENGTH OF THE CATHETER. 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. THE COMPLAINT WAS NOT CONFIRMED; NO FRICTION WAS FELT DURING FUNCTIONAL TESTING AND NO DAMAGE WAS FOUND INSIDE THE CATHETER. THE CAUSE OF THE KINKED SHAFT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS AND MAY BE RELATED TO POST-PROCEDURE HANDLING OR SHIPPING. CONTROLS ARE IN PLACE TO DETECT DAMAGED UNITS THROUGHOUT THE ASSEMBLY PROCESS OPERATIONS. THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED, HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. IT IS NOT KNOWN IF THE IVUS SYSTEM COULD HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT HAD A LESION IN THE LEFT RENAL ARTERY. THE BRACHIAL APPROACH WAS CHOSEN, AND A VISTA BRITE TIP GUIDING CATHETER WAS DELIVERED TO THE OSTIUM OF THE LEFT RENAL ARTERY. A GUIDEWIRE CROSSED THE LESION. FRICTION WAS FELT WHILE ADVANCING THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER IN THE GUIDING CATHETER. THEREFORE, THE CATHETER, WIRE AND IVUS CATHETER WERE WITHDRAWN. AFTER THE GUIDING CATHETER WAS REMOVED FROM THE PATIENT AND THE GUIDEWIRE LUMEN OF THE GUIDING CATHETER WAS FLUSHED, THE COATING OF THE CATHETER WAS DAMAGED. PART OF THE COATING CAME OUT OF THE CATHETER WHEN THE GUIDEWIRE LUMEN WAS FLUSHED. THEREFORE, ANOTHER GUIDING CATHETER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

    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 15174389

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR