BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 24069787 · Received January 14, 2026

    Report

    Report Number
    1820334-2026-00043
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    January 5, 2026
    Report Date
    February 18, 2026
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5. 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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

    H3 - DEVICE EVALUATED BY MFG?: DEVICE NOT RETURNED TO MANUFACTURER 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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

    IT WAS REPORTED IN ADDITIONAL INFORMATION PROVIDED 11FEB2026 THAT THE WIRE GUIDE WAS WITHDRAWN THROUGH THE SHEATH, NOT THROUGH A NEEDLE OR METAL CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN COOK MANDRIL WIRE SEPARATED. THE DEVICE WAS REQUIRED FOR NEPHROSTOMY TUBE PLACEMENT. DURING THE PROCEDURE, THE TIP OF THE WIRE BROKE OFF IN THE PATIENT AND WAS UNABLE TO BE RETRIEVED. THE NEPHROSTOMY TUBE WAS PLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS NOTED THAT THE PATIENT WAS VERY SICK PRIOR TO THE PROCEDURE AND THE FAMILY IS CONSIDERING COMFORT CARE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34316 DQX WIRE, GUIDE, CATHETER DQX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1