BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 6774082 · Received August 8, 2017

    Report

    Report Number
    1820334-2017-02203
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 21, 2017
    Report Date
    August 15, 2017
    Manufacturer
    COOK INC
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    K122796. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: ONE USED CXI SUPPORT CATHETER WAS RETURNED SEPARATED INTO TWO SECTIONS. THE PROXIMAL SECTION IS 30.5 CM IN LENGTH. A KINK IS NOTED 9.4 CM FROM THE PROXIMAL HUB. THE DISTAL SECTION IS 120.1 CM IN LENGTH. KINKS ARE NOTED AT 39.2 CM, 39.9 CM, 53.3 CM, 98.2 CM. AND 99.4 CM FROM THE PROXIMAL END OF THE DISTAL SEPARATED SECTION. DEVICE DIMENSIONS MET SPECIFICATION. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOWER LEG PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE CATHETER THROUGH THE SHEATH AND OBSERVED THE TIP HAD BROKEN OFF. THE TIP REMAINED INSIDE THE SHEATH AND DID NOT ENTER THE PATIENT. THE PROCEDURE WAS TERMINATED AS ANOTHER DEVICE WAS UNABLE TO CROSS THE LESION. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555100 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1