BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYB INTRODUCER, CATHETER

    MDR report key: 21422291 · Received February 20, 2025

    Report

    Report Number
    1820334-2025-00151
    Event Type
    Injury
    Date Received
    February 20, 2025
    Report Date
    June 19, 2025
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K240589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, WHILE BEING USED AS AN INDWELLING PERIPHERAL INTRAVENOUS LINE, AN UNSPECIFIED COOK 4-FRENCH MICROPUNCTURE CATHETER LEAKED AND SUBSEQUENTLY SEPARATED. APPROXIMATELY TWENTY-FOUR HOURS AFTER BEING PLACED IN THE ARM FOR INTRAVENOUS ACCESS, THE CATHETER WAS FOUND TO BE LEAKING. WHEN THE NURSE REMOVED THE CATHETER, IT BROKE OFF AND REMAINED IN THE PATIENT. PER THE REPORTER, THESE DEVICES ARE USED FOR INTRAVENOUS CATHETERS IN PATIENTS WITH "DIFFICULT ACCESS". INVESTIGATION EVALUATION: REVIEWS OF THE 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. THE LOT NUMBER WAS NOT PROVIDED TO COOK, AND A GLOBAL SHIPMENT SEARCH WAS UNABLE TO DEFINITIVELY DETERMINE THE LOT; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU STATES THAT THE DEVICE IS INTENDED FOR THE PLACEMENT OF WIRE GUIDES UP TO 0.038-INCH DIAMETER INTO THE PERIPHERAL VASCULAR SYSTEM WHEN A SMALL 21-GAUGE NEEDLE STICK IS DESIRED. THE IFU INSTRUCTS THE USER TO INSERT THE NEEDLE INTO THE VESSEL, ADVANCE THE WIRE THROUGH THE NEEDLE, REMOVE THE NEEDLE, ADVANCE THE INTRODUCER/DILATOR PAIR OVER THE WIRE, REMOVE THE DILATOR AND WIRE, ADVANCE A WIRE GUIDE UP TO 0.038-INCH DIAMETER THROUGH THE INTRODUCER, AND REMOVE THE INTRODUCER CATHETER, LEAVING THE WIRE IN PLACE, PRIOR TO PROCEEDING WITH THE PLANNED INTERVENTION. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT USER AND PROCEDURAL ISSUES, INCLUDING OFF-LABEL USE OF THE DEVICE, CONTRIBUTED TO THIS EVENT. THE DEVICE IS INTENDED TO FACILITATE PLACEMENT OF WIRE GUIDES AND THE IFU INSTRUCTS THE USER TO REMOVE THE INTRODUCER CATHETER PRIOR TO PROCEEDING WITH AN INTERVENTION. THE DEVICE IS NOT INTENDED TO BE USED AS AN INDWELLING INTRAVENOUS LINE. IT IS LIKELY THAT MANIPULATION OF THE CATHETER AND/OR PATIENT MOVEMENT WHILE THE CATHETER WAS IN PLACE CONTRIBUTED TO THE LEAK AND SUBSEQUENT SEPARATION. 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

    AS REPORTED, WHILE BEING USED AS AN INDWELLING PERIPHERAL INTRAVENOUS LINE, AN UNSPECIFIED COOK 4-FRENCH MICROPUNCTURE CATHETER LEAKED AND SUBSEQUENTLY SEPARATED. APPROXIMATELY TWENTY-FOUR HOURS AFTER BEING PLACED IN THE ARM FOR INTRAVENOUS ACCESS, THE CATHETER WAS FOUND TO BE LEAKING. WHEN THE NURSE REMOVED THE CATHETER, IT BROKE OFF AND REMAINED IN THE PATIENT. PER THE REPORTER, THESE DEVICES ARE USED FOR INTRAVENOUS CATHETERS IN PATIENTS WITH "DIFFICULT ACCESS". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424880 DYB INTRODUCER, CATHETER DYB COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown