BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 6486127 · Received April 12, 2017

    Report

    Report Number
    1820334-2017-00515
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 13, 2017
    Report Date
    June 5, 2017
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002231627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, TRENDS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE CXI SUPPORT CATHETER WAS RETURNED FOR EVALUATION. KINKS WERE LOCATED AT 16.7CM, 36.5CM, AND 66.8CM FROM THE PROXIMAL END AND A PORTION OF THE DISTAL TIP WAS SEPARATED. THE ATTACHED DISTAL TIP MEASURED 4.0MM. THE STRAIN RELIEF WAS ATTACHED AND SECURE. THE CATHETER AND SEPARATED TIP WERE TESTED WITH 0.014 INCH WIRE GUIDE AND NO OCCLUSIONS WERE NOTED. A DOCUMENT-BASED INVESTIGATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS ONE NONCONFORMING EVENT RELATED TO TIP DAMAGE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE, CONTRAINDICATIONS WARNINGS, AND PRECAUTIONS: PRECAUTIONS: THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN SMALL VESSEL ACCESS AND INTERVENTIONAL PROCEDURES. STANDARD TECHNIQUES FOR PLACEMENT OF PERCUTANEOUS CATHETERS SHOULD BE EMPLOYED. CATHETER MANIPULATION SHOULD ONLY OCCUR UNDER FLUOROSCOPY. THIS CATHETER IS DESIGNED AND INTENDED FOR ONE TIME USE ONLY. DO NOT RE-STERILIZE AND/OR REUSE. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K122796. THE DEVICE HAS BEEN REQUESTED AND NOT YET RECEIVED. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BELOW THE KNEE (BTK) PROCEDURE USING A CXI SUPPORT CATHETER, WHILE INTRODUCING THE CATHETER OVER THE WIRE PRIOR TO PATIENT CONTACT, THE TIP OF THE CXI CATHETER BROKE. THE PATIENT WAS UNHARMED AS THIS EVENT OCCURRED PRIOR TO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268404 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A 00827002231627

    Patients

    Seq Age Sex Outcome Treatment
    1