BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 9592919 · Received January 15, 2020

    Report

    Report Number
    1820334-2020-00127
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Report Date
    May 5, 2020
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002565517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY: AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE CXI CATHETER WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE CONFIRMED SEPARATION OF THE DARK GREY PORTION OF THE TIP NEAR THE DISTAL EDGE OF THE PLATINUM-IRIDIUM MARKER BAND. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER LOT-RELATED COMPLAINTS RECEIVED. REVIEWS OF THE MANUFACTURING INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE ALSO CONDUCTED, AND NO GAPS WERE DISCOVERED. THE AVAILABLE INFORMATION PROVIDES OBJECTIVE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE PRODUCT IS PACKAGED WITH INSTRUCTIONS FOR USE WHICH STATE, "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 AVAILABLE, INVESTIGATION HAS CONCLUDED THAT THE EVENT CAN BE TRACED TO RANDOM COMPONENT FAILURE. 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 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    OCCUPATION = NON-HEALTHCARE PROFESSIONAL. PMA/510(K) NUMBER = K122796. 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

    AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNKNOWN PROCEDURE, THE TIP OF A CXI SUPPORT CATHETER SEPARATED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55315 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G56551 9971325 00827002565517

    Patients

    Seq Age Sex Outcome Treatment
    1