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

Model Number N/A

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2023

Event Type  malfunction  

Event Description

Difficult advancement of the sheath over the balloon catheter from an ultraxx nephrostomy balloon and set was reported.The surgeon was utilizing the balloon in a percutaneous nephroscopic procedure.The balloon was filled to 15atm.When advancing the sheath canal over the balloon, it did not advance smoothly.It should be noted that the customer reported the balloon was not deflated when resistance was encountered.The procedure was completed with a percutaneous nephroscope dilator.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

E1- customer (person): line 2: (b)(6) / additional phone: (b)(6).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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: difficult advancement of the sheath over the balloon catheter from an ultraxx nephrostomy balloon and set was reported.The surgeon was utilizing the balloon in a percutaneous nephroscopic procedure.The balloon was filled to 15atm.When advancing the sheath canal over the balloon, it did not advance smoothly.It should be noted that the customer reported the balloon was not deflated when resistance was encountered.The procedure was completed with a percutaneous nephroscope dilator.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation ¿ evaluation interview of personnel, as well as, a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), and quality control procedures.One ultraxx nephrostomy balloon and set was returned for investigation.A function test was performed with the returned cook inflation device and there was no noted inflation issue.The sheath was also found to slide over the balloon without issue.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 found no non-conformances related to the reported failure mode.A review of complaint history records shows one other complaint reported by the same customer, for the same issue, associated with the complaint device lot.Due to the inspection methods and individual manufacturing nature of these devices it is unlikely that these two complaints signify an issue with the entire lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.The cause for this complaint was unable to be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRAXX NEPHROSTOMY BALLOON AND SET
• Type of Device: 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: 17577330
• MDR Text Key: 321644295
• Report Number: 1820334-2023-01115
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10827002460383
• UDI-Public: (01)10827002460383(17)250721(10)14852958
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNBS-8-15-CS
• Device Lot Number: 14852958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1