MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; FGE; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G09502
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pneumothorax (2012); Insufficient Information (4580)
Date of Event	06/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2a- additional common names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b- additional product codes: gbo; lje.E3 - occupation: clinical nurse educator.H3 - device evaluated by mfg: device evaluation anticipated but has not 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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported that the hub of an ultrathane mac-loc locking loop multipurpose drainage catheter detached.The device was placed in interventional radiology (b)(6) 2026 for the treatment of a right pleural effusion in an unknown patient.The drainage catheter was attached to a chest drainage system and drained 1100 ml fluid prior to being clamped.It was noted the following day that the hub had detached from the drain, with the suture string still attached holding both components together.It was said that the patient was compliant and did not appear to have been manipulating the tube.At the time of customer report, the device remained in place while they awaited a post x-ray and respirology/pulmonology evaluation.The customer's assessment of the detached hub noted that the connection below the luer lock seemed loose, possibly contributing to the tube being disconnected.They tried to replicate the issue with expired stock and noted that connection point is twisted on very tightly and could not be loosened.A customer provided photo of the device shows the mac-loc hub separated from the catheter shaft.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Event or Problem Description
The nursing staff reported in additional information that the patient was "compos mentis" or of sound mind and did not pull on the drainage catheter or get it caught on anything.The drain had been clamped high on the catheter shaft to temporarily stop drainage but was never clamped at the site of detachment.It was deemed unnecessary per mrp post x-ray to replace the drainage catheter.However, the patient developed a small pneumothorax.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b1, b2, b5, e4.Correction: h1, h6 (annexes e and f).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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: FGE; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 25550263
• Report Number: 1820334-2026-00646
• Device Sequence Number: 10741026
• Product Code: FGE
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)290325(10)17053688
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G09502
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 17053688
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEUR-EVAC.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown