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	G09504
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a: additional common names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b: additional product codes: gbo; lje.H3: device evaluated by mfg? no device return to manufacturer anticipated.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 mac-loc hubs of two ultrathane mac-loc locking loop multipurpose drainage catheter detached.Upon removal ("pulling the tubing") of the drainage catheters from an unknown patient, both hubs were said to detach.It is unknown how long the devices had been in place.The user was able to complete the removal of both drains without any harm to the patient.No portion of the devices remained inside the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event has been requested but is currently unavailable.
Event or Problem Description
In additional information received on 20mar2026, it was reported that the drains were not being removed when the detachment was noted; however, the drains were removed as a result of the hub separation.This occurred for 2 separate lots: 16627006 and 16623474.A photo provided by the customer confirms hub detachment from the catheter.This report captures hub separation occurring for lot 16627006.The additional complaint lot 16623474 is referenced in a report with patient identifier: (b)(6).
Additional Manufacturer Narrative
Additional information: b5, d4 - lot #, d4 - expiration date, d4 - primary udi number, h4 - device mfg date, e3.E3 - occupation: chief tech vascular institute & vascular admit & recovery unit.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5.Correction: d4 - lot #, d4 - expiration date, d4 - primary udi number, h4 - device mfg date (all unknown).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.
Event or Problem Description
It was discovered 26mar2026 that the lot numbers provided in additional information on 20mar2026 are incorrect, as they do not match the customer provided catalog number or photo of the device.The customer denies knowledge of other information available on the lot numbers.Therefore, the lot numbers will remain unknown; and this complaint file will capture both devices with unknown lot numbers (including the device from manufacturer reference #1820334-2026-00318).

• 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 (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 23840583
• Report Number: 1820334-2025-01576
• Device Sequence Number: 9957912
• Product Code: FGE
• UDI-Device Identifier: 00827002022782
• UDI-Public: (01)00827002022782(17)280603(10)16627006
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G09504
• Device Catalogue Number: ULT14.0-38-25-P-6S-CLM-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 03/20/2026; 03/26/2026; 04/27/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/24/2026; 04/07/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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
• Patient Sex: Unknown