BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 6364045 · Received February 28, 2017

    Report

    Report Number
    1820334-2017-00306
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    January 19, 2017
    Report Date
    July 10, 2017
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002565531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510(K) # K122796. (B)(4). THE REPORTED DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED CXI SUPPORT CATHETER WAS RETURNED FOR INVESTIGATION. THE GREEN HUB AND BLACK STRAIN RELIEF ARE ATTACHED TO EACH OTHER, BUT THEY ARE SEPARATED FROM THE CATHETER. APPROXIMATELY 1.0 CM PORTION OF CATHETER IS LODGED IN THE GREEN HUB. ADHESIVE IS PRESENT BETWEEN THE GREEN HUB AND BLACK STRAIN RELIEF. TWO KINKS WERE NOTED AT 2.8 CM AND 76.5 CM FROM THE PROXIMAL END IN THE CATHETER. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. 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 WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TRANSFEMORALE PUNCTURE PROCEDURE ON THE RIGHT SIDE, THE PHYSICIAN IMPLANTED A 4F SHEATH, INSERTED THE WIRE AND UTILIZED A CROSSOVER PROCEDURE WITH ANOTHER MANUFACTURER'S CATHETERS. THE BLACK AND GREEN HUB SEPARATED FROM THE CXI SUPPORT CATHETER. NO FEMORAL STENOSIS OR OCCLUSIONS WERE OBSERVED. OCCLUSION NOTED TIBIALIS POSTERIOR 5-10CM LENGTH. RECANALIZATION OF THE OCCLUSION WAS PERFORMED WITH FIRST THE V18, SUPPORTED WITH CXI 2.6 WITH THE "HAMMER" METHOD. THE PHYSICIAN HAD TO CHANGE THE WIRE, THE V18 WAS PULL OUT AND 18 ADVANTAGE WAS USED. DURING THIS CHANGE, IT WAS NOTED THAT THE HUB OF THE CXI WAS MISSING. THE PHYSICIAN HAD TO PERFORM THE RECANALIZATION AGAIN WITH A NEW CXI SUPPORT CATHETER. IT WAS STATED THE PHYSICIAN DID NOT EXERT FORCE DURING THE DEVICE HANDLING. THAT PATIENT REMAINED UNHARMED, A FRAGMENT WAS NOT INSIDE THE PATIENT'S BODY. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148669 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A 00827002565531

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR