BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 20524154 · Received October 24, 2024

    Report

    Report Number
    1820334-2024-01399
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    October 12, 2024
    Report Date
    August 12, 2025
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002095014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 E1- CUSTOMER (PERSON) : (B)(6). G4 - PMA/510(K): K173035 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 FOLLOWING INSERTION INTO A 64-YEAR-OLD FEMALE PATIENT DURING AN UNKNOWN PROCEDURE. THE CUSTOMER NOTED THAT THE CATHETER APPEARED TO BE RETRACTED AND FOLDED. AS A RESULT, THE CATHETER COULDN¿T ENTER COMPLETELY AND WAS REMOVED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A VIDEO PROVIDED BY THE CUSTOMER CONFIRMS THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736715 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC G09501 16022190 00827002095014

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female