BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 6563216 · Received May 12, 2017

    Report

    Report Number
    1820334-2017-01030
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    April 13, 2017
    Report Date
    June 23, 2017
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002565517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA / 510(K)# : K122796. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED AND DAMAGED CXI SUPPORT CATHETER (FINISHED GOODS LOT 6766174) WAS RETURNED FOR EVALUATION. DEVICE MEASUREMENTS FOR LENGTH, DIAMETER, AND DISTAL HOLE MET SPECIFICATION REQUIREMENTS. IN THE DEVICES RETURNED CONDITION, THE DISTAL TIP LENGTH MEASUREMENT WAS OUT OF SPECIFICATION. REVIEW OF DEVICE HISTORY RECORD SHOWS ONE NONCONFORMING EVENT RELATED TO THIS FAILURE MODE. NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER 6766174 WERE IDENTIFIED. BASED ON THE INFORMATION PROVIDED,AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE CXI SUPPORT CATHETER BROKE OFF "WITHOUT ANY MASSIV(E) PUSH" BEFORE A PROCEDURE. THERE WAS REPORTEDLY NO PATIENT INVOLVED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344929 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A 00827002565517

    Patients

    Seq Age Sex Outcome Treatment
    1