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.E3 - occupation: chief tech vascular institute & vascular admit & recovery unit.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.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.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.This report captures hub separation occurring for lot 16623474.Complaint lot 16627006 is referenced in a report with patient identifier: (b)(6).
Event or Problem Description
See h11.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate this complaint file will be close cancelled.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.Both devices with unknown lot numbers will be addressed in the report with manufacturer reference #1820334-2025-01576, and this complaint file will be close canceled.No additional reports will be sent under this reference number, #1820334-2026-00318.Please see manufacturer reference #1820334-2025-01576 for any further information.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.

• 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: 24681995
• Report Number: 1820334-2026-00318
• Device Sequence Number: 9706436
• Product Code: FGE
• UDI-Device Identifier: 00827002022782
• UDI-Public: (01)00827002022782(17)280530(10)16623474
• 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
• Report Date (Section B): 04/07/2026

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: 16623474
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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