BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 24434903 · Received February 24, 2026

    Report

    Report Number
    1820334-2026-00216
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    December 30, 2024
    Report Date
    April 21, 2026
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002094987
    PMA / PMN Number
    K173035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: ADDITIONAL COMMON NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B: ADDITIONAL PRODUCT CODES: GBO; LJE. E1: PHONE NUMBER: (B)(6). H3: THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. 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. 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

    IT WAS REPORTED THAT THE BLUE FLEXIBLE STIFFENING CANNULA WAS INADVERTENTLY LEFT IN AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER DURING A ROUTINE BILIARY DRAIN EXCHANGE FOR AN UNKNOWN PATIENT. THIS WAS NOT DISCOVERED UNTIL TWO WEEKS AFTER IMPLANTATION WHEN IT WAS NOTED THAT THE DRAINAGE CATHETER WAS NOT DRAINING PROPERLY. IT WAS REPORTED IN ADDITIONAL INFORMATION PROVIDED 15FEB2026, THAT THERE WAS NO MALFUNCTION OF THE DEVICE. HOWEVER, THE DRAINAGE CATHETER REQUIRED REPLACEMENT TWO WEEKS AFTER PLACEMENT; THUS, PROMPTING THIS REPORT. THE DEVICE WAS REMOVED AND DISCARDED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50547 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FGE; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK INC G09498 16251627 00827002094987

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention