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	G09501
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a: common device name: additional names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b: product code: additional product codes: gbo, lje.E1: phone: (b)(6).H3: device evaluated by mfg: device evaluation anticipated but has 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.
Event or Problem Description
It was reported that the stiffening cannula of an ultrathane mac-loc locking loop multipurpose drainage catheter was difficult to remove during a percutaneous transhepatic cholangiography drainage (ptcd) procedure for a 51-year-old male patient.After the device was opened and introduced into the biliary tract of the patient, significant resistance was encountered when attempting to withdraw the stiffener from the catheter.The stiffening cannula and catheter were then removed from the patient as a unit.Following removal, further attempts to remove the stiffener from the catheter were unsuccessful.A new drainage catheter was then opened to complete the procedure successfully.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d9 - date returned to mfg investigation ¿ evaluation it was reported that the stiffening cannula of an ultrathane mac-loc locking loop multipurpose drainage catheter was difficult to remove during a percutaneous transhepatic cholangiography drainage (ptcd) procedure.After the device was opened and introduced into the biliary tract of the patient, significant resistance was encountered when attempting to withdraw the stiffener from the catheter.The stiffening cannula and catheter were then removed from the patient as a unit.Following removal, further attempts to remove the stiffener from the catheter were unsuccessful.A new drainage catheter was then opened to complete the procedure successfully.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, specifications, and instructions for use (ifu), as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.One used catheter was returned to cook for evaluation.Upon visual inspection, it was noted that the stiffening cannula and trocar were inserted in the catheter and were protruding through the distal tip of the catheter.A functional test of the device confirmed the cannula was difficult to remove from the catheter; however, the cannula was eventually removed with twisting and backward traction.After flushing the catheter, the metal stiffener was reinserted and removed without difficulty.Dimensional verification confirmed the catheter's internal diameter and the stiffening cannula's outer diameter were within specification.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot and the related subassembly lots did not reveal any quality control discrepancies.A complaint history search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming products exist either in house or in field.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ instructions for use: ¿under fluoroscopic control, perform standard techniques for placement of percutaneous draining catheters, either by seldinger access or trocar access.-once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to for its configuration.¿ how supplied: ¿supplied sterilize by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred.¿ based on the available information, inspection of the returned device, and the results of the investigation, cook medical has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 23534316
• Report Number: 1820334-2025-01402
• Device Sequence Number: 9140521
• Product Code: FGE
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)280501(10)16581831
• 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
• Report Date (Section B): 03/18/2026

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: G09501
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 16581831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: Asian