BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 23760891 · Received December 9, 2025

    Report

    Report Number
    1820334-2025-01532
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    December 4, 2025
    Report Date
    April 28, 2026
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002095014
    PMA / PMN Number
    K173035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B - PRODUCT CODE: ADDITIONAL PRODUCT CODES: GBO, LJE. H3 - 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 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 STIFFENING CANNULA OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE DURING PLACEMENT INTO THE BILIARY TRACT OF A 59-YEAR-OLD FEMALE PATIENT. FOLLOWING CATHETER PLACEMENT INTO THE PATIENT, THE PHYSICIAN ENCOUNTERED RESISTANCE DURING ATTEMPTED REMOVAL OF THE STIFFENING CANNULA. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE STIFFENER; HOWEVER, ALL WERE UNSUCCESSFUL. THE STIFFENER AND CATHETER WERE THEN REMOVED FROM THE PATIENT AS A UNIT, AND A NEW LIKE-DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586667 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE, STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK INC G09501 15756730 00827002095014

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female