BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 25058422 · Received May 1, 2026

    Report

    Report Number
    1820334-2026-00471
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 1, 2026
    Manufacturer
    COOK INC
    Product Code
    FGE
    PMA / PMN Number
    K173035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    .. D2A- ADDITIONAL COMMON NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B- ADDITIONAL PRODUCT CODES: GBO; LJE D4 - 2 POSSIBLE LOT #S: 16896059 OR 16839285. D4 - EXPIRATION DATE: 08DEC2028 OR 23OCT2028 D4 - PRIMARY UDI NUMBER: (B)(4). H4 - DEVICE MFG DATE: 08DEC2025 OR 23OCT2025. 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 FLEXIBLE STIFFENING CANNULA WAS DIFFICULT TO REMOVE FROM AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DURING AN UNSPECIFIED PROCEDURE FOR A FEMALE PATIENT. THE STIFFENING CANNULA SEEMED TO "STICK" TOWARD THE BOTTOM OF THE DRAINAGE CATHETER AND BECAME DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED "JUST FINE", ONLY EXPERIENCING A DELAY WITH THE DIFFICULTY OF REMOVING THE FLEXIBLE STIFFENER. IT SHOULD BE NOTED THAT TWO DEVICES WERE PLACED IN THE PATIENT, AND SO IT CANNOT BE CONFIRMED WITH WHICH DEVICE LOT THE USER EXPERIENCED DIFFICULTY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176722 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK INC G09641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female