BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 24617710 · Received March 17, 2026

    Report

    Report Number
    1820334-2026-00288
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    March 13, 2026
    Report Date
    March 17, 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

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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 - DEVICE EVALUATION ANTICIPATED BUT 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 AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS RUPTURED AT THE DISTAL SIDE HOLE. DURING PREP OF THE DEVICE, THE DRAINAGE CATHETER WAS RINSED WITH SALINE. IT WAS THEN THAT THE DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. A CUSTOMER PROVIDED PHOTO REVEALS A TEAR IN THE CATHETER COMING FROM THE SIDE HOLE. 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
    675801 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK INC G09501 16736779 00827002095014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown