MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G09501
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
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: customer (person): address line 2: (b)(6).G4: pma/510(k)#: k173035.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 an ultrathane mac-loc locking loop multipurpose drainage catheter leaked following an unspecified procedure on a 53-year-old male patient.The patient underwent catheter placement on (b)(6) 2024.The procedure was completed without any complications; however, upon patient¿s return to the ward at the end of procedure, the nurse observed that the catheter was leaking.The nurse applied tape around the leakage and continued using it.The device failure was reported following removal of the drainage catheter from the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.A photo and video provided by the customer show fluid leakage from the mac-loc assembly.
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, unchanged or unavailable.Investigation ¿ evaluation: it was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter leaked following an unspecified procedure on a 53-year-old male patient.The patient underwent catheter placement on (b)(6) 2024.The procedure was completed without any complications; however, upon patient¿s return to the ward at the end of procedure, the nurse observed that the catheter was leaking.The nurse applied tape around the leakage and continued using it.The device failure was reported following removal of the drainage catheter from the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.A photo and video provided by the customer show fluid leakage from the mac-loc assembly.Reviews of the documentation, including the complaint history, device history record, quality control procedures and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used ultrathane mac-loc locking loop multipurpose drainage catheter was received in a used and damaged condition.The initial investigation confirmed the device passed the gap gauge requirement.During testing, the investigation confirmed leakage at the proximal end where the catheter is connected to the mac-loc adaptor.The flare was observed to be folded over the opening of the mac-loc adaptor.The suture line was confirmed to be properly anchored between the cap and mac-loc adaptor.The investigation also identified a section of the catheter shaft, along with the mac-loc adaptor, was cut off from the catheter shaft.This most likely was performed by the end user to remove from the patient.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that inspection activities are in place to prevent the release of non-conforming product related to the reported failure mode.A review of the device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the instructions for use (ifu) [ t_multi2 rev1, multipurpose drainage catheter] states the following.How supplied: "upon removal from package, inspect the product to ensure no damage has occurred." evidence gathered upon review of device master record (dmr), instructions for use (ifu), device history record (dhr), and the device evaluation, it appears that the device was manufactured outside of specifications.However, since no further complaints have been reported from the specific lot, and the expanded lot search yielded no additional issues, there is no evidence of any other nonconforming devices either in-house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a component failure is manufacturing related, due to an isolated flare.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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 CATHETER, BILIARY, DIAGNOSTIC
• 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: 20345260
• Report Number: 1820334-2024-01292
• Device Sequence Number: 18116673
• Product Code: FGE
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)270306(10)15931893
• Combination Product (Y/N): N
• 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): 05/02/2025

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: 15931893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2024
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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: 53 YR
• Patient Sex: Male