BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 6820365 · Received August 25, 2017

    Report

    Report Number
    1820334-2017-02708
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    August 18, 2017
    Report Date
    September 18, 2017
    Manufacturer
    COOK INC
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K122796. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD, NONCONFORMANCE HISTORY, AND QUERY FOR PRODUCT EVENTS 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. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A CXI SUPPORT CATHETER WAS BEING PREPARED TO BE USED IN A LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION. IT WAS REPORTED THAT WHEN LOADING THE CATHETER ONTO THE APPROACH CTO WIRE, THE TIP BECAME STUCK ON THE WIRE. UPON REMOVAL OF THE CATHETER, THE TIP SEPARATED AND REMAINED ON THE WIRE. THE WIRE, ALONG WITH THE CATHETER TIP, WAS REMOVED AND ANOTHER DEVICE WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601668 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1