BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 8284767 · Received January 29, 2019

    Report

    Report Number
    1820334-2019-00182
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    January 14, 2019
    Report Date
    March 5, 2019
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002500020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURERS INSTRUCTIONS, QUALITY CONTROL, AND A FUNCTIONAL TEST & VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT ONE USED CXI-2.6-18-90-P-NS-ANG CXI SUPPORT CATHETER WAS RETURNED FOR INVESTIGATION ALONG WITH 2 PIECES OF BLACK MATERIAL. A KINK WAS NOTED AT THE END OF THE STRAIN RELIEF. HOWEVER, THE 4MM DISTAL TIP OF THE DEVICE WAS INTACT WHICH WAS INCONSISTENT WITH THE INITIAL REPORT. UPON INVESTIGATION, THE RETURNED SEGMENTED MATERIAL WAS DETERMINED NOT TO BE FROM THE COMPLAINT DEVICE. THE BLACK TUBING RECEIVED HAD A LUMEN AND A .014 WIRE WAS ABLE TO ENTER THE OPEN LUMEN WITHOUT ISSUES. DURING THE FUNCTIONAL REST, A .018 WIRE GUIDE WAS ALSO ABLE TO PASS THROUGH THE COMPLAINT DEVICE WITH A SMOOTH TRANSITION. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED ONE NONCONFORMING EVENT WHICH COULD POTENTIALLY CONTRIBUTE TO THIS FAILURE MODE. THIS NONCONFORMANCE WAS FOR TIP DAMAGE, HOWEVER THE AFFECTED UNIT WAS SCRAPPED AND NOT REPLACED PRIOR TO ORDER COMPLETION. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, A REVIEW OF THE MANUFACTURES INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WAS CONDUCTED, AND NO GAPS WERE DISCOVERED. MOREOVER, AN IFU IS PROVIDED WITH THE DEVICE, WHICH STATES ¿THE CATHETER SHOULD NOT BE ADVANCED THROUGH AN AREA OF RESISTANCE UNLESS THE SOURCE OF RESISTANCE IS IDENTIFIED BY FLUOROSCOPY AND APPROPRIATE STEPS ARE TAKEN TO REDUCE OR REMOVE THE OBSTRUCTION." BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER = K160884. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE INVOLVING A CHRONIC TOTAL OCCLUSION (CTO) OF THE FEMORAL AND POPLITEAL ARTERIES, A CXI SUPPORT CATHETER SEPARATED. THE LESION WAS REPORTED TO BE HEAVILY CALCIFIED AND THE DEVICE WAS UNABLE TO CROSS THE LESION. WHEN THE COMPLAINT DEVICE WAS REMOVED, THE TIP HAD ALLEGEDLY BROKEN OFF INSIDE THE PATIENT. THE TIP WAS RETRIEVED FROM THE PATIENT WITH THE LOOP OF A WIRE, PER THE INITIAL REPORTER. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80023 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC 9307146 00827002500020

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention