BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 10460677 · Received August 27, 2020

    Report

    Report Number
    1820334-2020-01571
    Event Type
    Injury
    Date Received
    August 27, 2020
    Report Date
    February 18, 2021
    Manufacturer
    COOK INC
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, AN UNSPECIFIED 0.014 OR 0.018 COOK CXI SUPPORT CATHETER SEPARATED AT THE TIP. THE TIP OF THE DEVICE REMAINED IN THE PATIENT. 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 DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. A LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CARRIED OUT. COOK COMPLETED A REVIEW OF THE DEVICE MASTER RECORD INCLUDING QUALITY CONTROLS, MANUFACTURING INSTRUCTIONS, PRODUCT LABELLING AND DESIGN HISTORY FILE. IT WAS CONCLUDED THAT THERE ARE SUFFICIENT CONTROLS IN PLACE TO MITIGATE THE RISK OF THIS FAILURE MODE. THE IFU FOR THIS PRODUCT CAUTIONS AGAINST ADVANCEMENT OF THE DEVICE THOUGH RESISTANCE AND INSTRUCTS THE USER NOT TO ADVANCE THE CATHETER INTO A VESSEL HAVING A REFERENCE DIAMETER SMALLER THAN THE CATHETER OUTSIDE DIAMETER. BASED ON THE LIMITED INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED NOR WAS THE COMPLAINT DEVICE RETURNED. WITH CURRENT INFORMATION, POSSIBLE CAUSES FOR THIS COMPLAINT INCLUDING PATIENT ANATOMY, PROCEDURAL/USER ISSUES, OR MANUFACTURING CANNOT BE RULED OUT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. PMA/510(K) NUMBER = ALTHOUGH THE EXACT PRODUCT INFORMATION IS UNKNOWN, THE 510(K) FOR CXI SUPPORT CATHETERS IS EITHER K122796 OR K16088. 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, DURING AN UNKNOWN PROCEDURE, AN UNSPECIFIED 0.014 OR 0.018 COOK CXI SUPPORT CATHETER SEPARATED AT THE TIP. THE TIP OF THE DEVICE REMAINED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME. 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
    924024 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other