MAUDE Adverse Event Report: COOK INC ULTRAXX NEPHROSTOMY BALLOON AND SET; LJE CATHETER, NEPHROSTOMY

Model Number	G47649
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 ¿ the device is not being returned for evaluation.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, during a percutaneous nephrolithotomy (pcnl), the sheath of a ultraxx nephrostomy balloon and set deformed when the physician attempted to place it over the balloon.According to the nurse manager, the case was aborted due to lack of successful access, unrelated to the device.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Event or Problem Description
Additional information was received 20feb2026.Per the reporter, it is unknown what pressure/volume was the balloon inflated to.The procedure was completed successfully using another 'ultraxx nephrostomy balloon and set'.
Additional Manufacturer Narrative
Additional information: b5 corrected information: h6 (annex e, f and g).Investigation ¿ evaluation it was reported, during a percutaneous nephrolithotomy (pcnl), the sheath of a ultraxx nephrostomy balloon and set deformed when the physician attempted to place it over the balloon.Another new device was used to complete the procedure.No adverse effects were reported.Reviews of documentation including the complaint history, device history record (dhr), quality control (qc) procedures, and instructions for use (ifu), and customer provided photo, were conducted during the investigation.The complaint device was not returned to cook for evaluation.Therefore, no physical examinations could be conducted.However, a provided photo of the complaint device showed that the sheath was deformed.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 device history record (dhr) found no related non-conformances that could have contributed to the reported failure mode.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.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.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: 'how supplied: -upon removal from package, inspect the product to ensure no damage has occurred.' based on the available information, no product returned, and the results of the investigation, cook has concluded a definitive cause could not be determined from the available information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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: ULTRAXX NEPHROSTOMY BALLOON AND SET
• 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: 23756000
• Report Number: 1820334-2025-01522
• Device Sequence Number: 9583762
• Product Code: LJE
• UDI-Device Identifier: 00827002476493
• UDI-Public: (01)00827002476493(17)280430(10)16772944
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: G47649
• Device Catalogue Number: UNBS-10-15-01
• Device Lot Number: 16772944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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 Sex: Female