BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 7280791 · Received February 19, 2018

    Report

    Report Number
    1820334-2018-00404
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Date of Event
    February 6, 2018
    Report Date
    April 19, 2018
    Manufacturer
    COOK INC
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER = K122796 (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND A VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE PRESENCE OF A KINK IN THE CATHETER SHAFT, WHICH WAS NOTED AT A DISTANCE OF APPROXIMATELY 63 CM FROM THE PROXIMAL HUB. NO OTHER DAMAGE TO THE CATHETER SHAFT WAS NOTED. THE TIP WAS SPLIT APPROXIMATELY 2.5 MM FROM THE DISTAL END OF THE DEVICE. THE WIRE EXITED THROUGH THE SPLIT. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. 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, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN "FSA RIGHT SIDE" PROCEDURE, A WIRE GUIDE WAS ATTEMPTED TO BE ADVANCED INTO THE ANGLED CXI SUPPORT CATHETER. THE WIRE GUIDE PERFORATED THE CATHETER IN THE ANKLE OF THE BEND. THE PATIENT'S VESSELS WERE NOTED TO BE CALCIFIED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.  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
    123880 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1