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	G09498
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that leakage was observed at the hub of an ultrathane mac-loc locking loop biliary drainage catheter sometime after placement for a percutaneous transhepatic cholangiography (ptc) procedure.As a result, the patient was sedated a second time for the complaint device to be removed and replaced.No other adverse effects were reported for this incident.Additional information regarding event details has been requested but is currently unavailable.
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 - street: (b)(6).E1 - phone number: (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 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
In additional information reported on 11feb2026, it was noted that hub leakage was discovered about 10-15 minutes after placement, as the radiographer connected the drain.The patient's preparation was then restarted, and the drain was replaced with a new one.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Additional information: d9 - date returned to mfr.Investigation ¿ evaluation it was reported that leakage was observed at the hub of an ultrathane mac-loc locking loop biliary drainage catheter after a percutaneous transhepatic cholangiography (ptc) procedure.This was noted as the radiographer was connecting the drain about 10-15 minutes after placement.As a result, the patient was sedated again, and preparation was performed a second time for the complaint device to be removed and replaced.No other adverse effects were reported for this incident.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.The ultrathane mac-loc locking loop multipurpose drainage set was returned in a used and damaged condition.Physical inspection and functional testing confirmed leakage at the interface between the cap and the mac-loc adaptor.No damage was observed on the flare during inspection of the mac-loc adaptor lumen.The distance between the cap and the hub was measured and determined to be within specification.Additionally, the black suture string was found to be broken, resulting in disengagement from the locking lever.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 dhr for the reported complaint device lot showed that 1 device was reworked for a potentially related quality control discrepancy.The remainder of the lot was inspected with 100% inspection activities.The sub assembly lots for the mac-loc assembly had no quality control discrepancies.A complaint history search identified no other events reported for the related failure mode.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: precautions: patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.How supplied upon removal from 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 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, 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.

• 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: 24306120
• Report Number: 1820334-2026-00158
• Device Sequence Number: 12072133
• Product Code: FGE
• Combination Product (Y/N): N
• 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: Other,Foreign,User Facility
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 16730312
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 02/11/2026; 05/07/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/12/2026; 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown