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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ultrathane mac-loc locking loop multipurpose drainage catheter leaked during a percutaneous transhepatic drainage (ptcd) procedure.After placement of the drainage catheter into the patient, leakage was observed at the sealing of the drainage tube interface.As a result, another device was used to continue the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.A photo provided by the customer shows the location of the leak to be at the mac-loc assembly.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D2a - common device name: additional names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy d2b - procode: additional product codes: gbo, lje.E1: customer person- address: (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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation / evaluation: it was reported that the ultrathane mac-loc locking loop multipurpose drainage catheter leaked during a percutaneous transhepatic drainage (ptcd) procedure.After placement of the drainage catheter into the patient, leakage was observed at the sealing of the drainage tube interface.As a result, another device was used to continue the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.A photo provided by the customer shows the location of the leak to be at 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.An ultrathane mac-loc locking loop multipurpose drainage catheter, was received in a used condition.The device arrived with the lever on the mac-loc adaptor in an unlocked position.During testing, leakage was observed when the lever was in the unlocked position.However, no leakage was detected when the lever was locked.The lumen of the mac-loc adaptor was unobstructed and met the gap gauge requirements.The supplied components were received sealed within their appropriate inner pouches.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 nonconformance's 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: cook reviewed the product labeling for the complaint device.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 dmr, ifu, dhr and device evaluation suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that the main cause of the event could not be established.It is possible the locking lever of the mac-loc adaptor was not properly positioned, thus allowing leakage to occur.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: 20053774
• Report Number: 1820334-2024-01108
• Device Sequence Number: 15453350
• Product Code: FGE
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)261031(10)15733872
• 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): 04/03/2025

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: 15733872
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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