MAUDE Adverse Event Report: COOK INC; FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G09498
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hair-like fiber was found in the sealed packaging of an ultrathane mac-loc locking loop biliary drainage catheter.The device was not opened and did not make patient contact.The customer provided a photo revealing a hair-like fiber in the packaging.No adverse effects were reported for this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D1 - brand name: ultrathane mac-loc locking loop biliary drainage catheter d2a- additional common names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b- additional product codes: gbo; lje h3 - 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
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: b3, e4, d9 - date returned to mfg.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.
Additional Manufacturer Narrative
Investigation ¿ evaluation it was reported that a hair-like fiber was found in the sealed packaging of an ultrathane mac-loc locking loop biliary drainage catheter.The device was not opened and did not make patient contact.The customer provided a photo revealing a hair-like fiber in the packaging.No adverse effects were reported for this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One ultrathane mac-loc locking loop biliary drainage catheter was received sealed and unused.A visual examination confirmed that foreign matter, (a single strand, from an unknown source) was present within the sealed packaging.Cook determined that the device was manufactured out of 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 dhr for the reported complaint device lot discovered two relevant recorded quality control discrepancies involving a total of 3 units.All packages were scrapped before further processing of the order.A complaint history search identified no other events reported for the related failure mode.Additional related lots were also reviewed, and no other confirmed instances of this failure mode were noted from these lots.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The current instructions for use [ifu__multi2_rev1] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: how supplied: upon the removal from the package, inspect the product to ensure no damage has occurred.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has determined that the primary cause of the issue is manufacturing related.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, that a death or serious injury occurred, nor 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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 23638667
• Report Number: 1820334-2025-01463
• Device Sequence Number: 15880881
• Product Code: FGE
• UDI-Device Identifier: 00827002094987
• UDI-Public: (01)00827002094987(17)280929(10)16802615
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 04/24/2026

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: G09498
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Device Lot Number: 16802615
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 04/21/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/26/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2025
• 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