BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 24453639 · Received February 26, 2026

    Report

    Report Number
    1820334-2026-00220
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    December 10, 2025
    Report Date
    February 26, 2026
    Manufacturer
    COOK INC
    Product Code
    FGE
    PMA / PMN Number
    K173035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NAME: ADDITIONAL NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY PRODUCT CODE: ADDITIONAL PRODUCT CODES: GBO, LJE E1 - PHONE: (B)(6). E3 - OCCUPATION: REGULATORY AFFAIRS SPECIALIST. DEVICE EVALUATED BY MFG: DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. AWAITING DEVICE RETURN. 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 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 STIFFENING CANNULA OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE DURING PLACEMENT OF THE DEVICE INTO THE GALLBLADDER OF A 75-YEAR-OLD FEMALE PATIENT. AS A RESULT, THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT AND DISCARDED. A NEW LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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
    119425 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK INC G09502

    Patients

    Seq Age Sex Outcome Treatment
    1