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 Codes	Break (1069); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
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 suture of an ultrathane mac-loc locking loop multipurpose drainage catheter broke following a gastrointestinal procedure for a 65-year-old female patient.The drainage catheter was placed in the patient.However, the drainage rate was significantly below expected norms.After excluding operational errors and patient-specific factors, it was determined that the catheter suture had separated.The catheter remained in situ for three hours before the failure was noticed.The defective device was promptly removed and replaced with a new drainage catheter.No other adverse effects were reported for this incident.
Event or Problem Description
The device was returned to the manufacturer on 11sep2025.During the preliminary device failure analysis, it was found that the suture string was not broken.It is believed that the slow rate of drainage led to the removal and replacement of the complaint device.
Additional Manufacturer Narrative
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
Correction: d4 - primary udi number investigation ¿ evaluation it was reported that the suture of an ultrathane mac-loc locking loop multipurpose drainage catheter broke after placement for a 65-year-old female patient.The drainage catheter was placed in the patient following a pelvic gastrointestinal procedure.However, the drainage rate was slower than expected norms.After ruling out operational and patient-specific factors, it was determined the catheter suture had separated.The device was removed 3 hours after placement and was promptly replaced with a new drainage catheter.No other adverse events were reported.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), specifications, 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 catheter was returned in an open and used condition.Both the stiffening cannula and trocar were present and had been inserted into the catheter.Dried biological residue was observed throughout the catheter¿s length, including within the side ports.Upon removal of the stiffening cannula, the black suture string was engaged, successfully forming the intended loop configuration.The locking lever operated as designed.Re-insertion of the stiffening cannula followed by the trocar was performed without issue.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 confirmed there were no relevant recorded discrepancies.To date, a further search of the subject lot in our database records confirmed 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.Cook also reviewed product labeling.The manufacturer does not apply an ifu for this product.Instructions for use are applied by the local distribution partner.Based on the information provided, inspection of the returned device, and the results of the investigation, cook medical has concluded that the cause category would fall under no problem detected.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 22895419
• Report Number: 1820334-2025-01064
• Device Sequence Number: 12985832
• Product Code: FGE
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)280602(10)16624706
• 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): 02/25/2026

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: G09501
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 16624706
• 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: 09/11/2025; 02/20/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/23/2025; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 70 KG