MAUDE Adverse Event Report: COOK INC UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER; LJE CATHETER, NEPHROSTOMY

Model Number	G55803
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer additional phone = (b)(6).E3: customer occupation: quality assistant.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 the 'universa loop nephrostomy percutaneous drainage catheters' the wire guide "detached" from the device during the nephrostomy procedure.The issue was found during device placement, and no other devices were used with the wire guide.The procedure was completed by using another device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional information has been requested but is unavailable at this time.
Additional Manufacturer Narrative
Investigation ¿ evaluation it was reported that the 'universa loop nephrostomy percutaneous drainage catheters' the wire guide "detached" from the device during the nephrostomy procedure.The issue was found during device placement, and no other devices were used with the wire guide.The procedure was completed by using another device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record (dhr), quality control procedures and instructions for use (ifu) as well as a visual inspection of the returned device, were conducted during the investigation.A device failure analysis was conducted.Upon inspection there were a few significant amount of bends/kinks in the wire guide.The wire guide could not be removed from the needle cannula as when attempting to remove the wire guide, the coils separated exposing the inner core.There was no coating coming off the wire guide.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspections are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for the device lot found no relevant nonconformances that could have contributed to the reported failure mode.A complaint history search identified one other event associated with the reported device lot for a different failure mode.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Product labeling review: the product ifu, [t_ulcs_rev4] ¿universa loop drainage catheter set¿ contains the following information to the user related to the reported failure mode.¿precautions¿ do not forcefully advance any component during removal or replacement of the catheter.Carefully remove the components if any resistance is encountered.¿ ¿how supplied" upon removal from the package, inspect the product to ensure no damage has occurred.¿ based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a definitive cause of the event could not be determined.The root cause of the failure was thought to likely be due to the wire guide becoming stuck in the needle cannula.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.
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: UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER
• Common Device Name: LJE CATHETER, NEPHROSTOMY
• 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: 20749334
• Report Number: 1820334-2024-01533
• Device Sequence Number: 8376962
• Product Code: LJE
• UDI-Device Identifier: 00827002558038
• UDI-Public: (01)00827002558038(17)260202(10)15204319
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140085
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Expiration Date: 02/02/2026
• Device Model Number: G55803
• Device Catalogue Number: ULCS-12-30
• Device Lot Number: 15204319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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: Female