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	08/15/2025
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.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 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 metal stiffening cannula was difficult to remove from the ultrathane mac-loc locking loop multipurpose drainage catheter.During a percutaneous transhepatic biliary drainage (ptcd) procedure, the cannula was difficult to advance.Once the cannula was advanced, it became lodged in the catheter and could not be removed.The device components were removed together, and a new like device was used to complete the procedure.As reported, 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 unchanged, unknown, or unavailable.Correction: d4 - primary udi number.Investigation ¿ evaluation: it was reported that the metal stiffening cannula was difficult to remove from the ultrathane mac-loc locking loop multipurpose drainage catheter.During a percutaneous transhepatic biliary drainage (ptcd) procedure, the cannula was difficult to advance.Once the cannula was advanced, it became lodged in the catheter and could not be removed.The device components were removed together, and a new like device was used to complete the procedure.As reported, 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, and specifications, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.Cook received one drainage catheter with the obturator and stiffening cannula still inserted.Upon attempt to remove the stiffener from the catheter, difficulty was encountered.The catheter was manipulated by twisting the end and pulling back on the stiffening cannula; heavy presence of biomatter was noted.After cleaning the device, there was no difficulty with reinsertion or removal of the stiffening cannula from the catheter.The catheter id and stiffener od were confirmed to be 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 dhr for the reported complaint device lot and the related subassembly lots confirmed no discrepancies during the incoming qc inspection process.To date, a thorough search of our database records has confirmed that there have been no additional complaints associated with the reported lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.The instructions for use (ifu__multi2_rev1) are not included with this lot.The manufacturer does not provide an ifu for this product; instead, the local distribution partner is responsible for supplying the applicable instructions for use 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 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: 22855811
• Report Number: 1820334-2025-01034
• Device Sequence Number: 18235945
• Product Code: FGE
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)280604(10)16628934
• 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): 01/15/2026

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: 16628934
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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: 63 YR
• Patient Sex: Male