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

Model Number	G09497
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	03/11/2026
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 e1 - phone number: (b)(6).H3 ¿ the device is not being returned for evaluation.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.
Event or Problem Description
It was reported that the stiffening cannula was difficult to remove from an ultrathane mac-loc locking loop biliary drainage catheter.The device was required for biliary drainage during a percutaneous transhepatic cholangiography and drainage (ptcd) procedure.The stiffening cannula became lodged at the pigtail tip of the catheter, making it difficult to remove.This led to pain, biliary tract injury, and minor bleeding for the patient.The catheter and stiffening cannula were removed together, and a new like device was used to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Additional information: b5.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
Additional information was provided.As reported, the incident was caused by improper operation resulting in product damage.The patient had minimal bleeding, which required no intervention and resolved spontaneously.The procedure was then completed by replacing with a product from the same lot.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY 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: 24790749
• Report Number: 1820334-2026-00371
• Device Sequence Number: 18644977
• Product Code: FGE
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)280428(10)16576322
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2026

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: G09497
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 16576322
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 05/15/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/17/2026; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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 Age: 70 YR
• Patient Sex: Male