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 08/23/2023

Event Type  malfunction  

Event Description

It was reported that the outer sheath in a ultraxx nephrostomy balloon and set could not advance over the inflated balloon catheter smoothly during a percutaneous nephrostomy procedure in an unknown patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported that the outer sheath in an ultraxx nephrostomy balloon and set could not advance over the inflated balloon catheter smoothly during a percutaneous nephrostomy procedure in an unknown patient.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the complaint history, device history record (dhr), and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.The device was returned and inspected.A function test was performed with the returned cook inflation device and no inflation issue was noted.The sheath was attempted to be slid over the balloon at inflation pressures of 20, 15, 12, and 10 atm.Only once the pressure was decreased to 10 atm was the sheath able to fully advance over the balloon.There is no evidence to suggest that the product was not manufactured to the appropriate specifications.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also completed a review of the dhr for the reported lot, and no related nonconformances were noted.A historic lot search was also conducted, and no additional customer complaints have been received.There is no evidence to suggest other items in the lot or similar devices in house or in the filed are nonconforming.Cook was unable to review the product labeling for this device as the lot was exempted from an ifu due to the destination country.Based on the information provided, inspection of the returned device, and the results of the investigation, the cause for this complaint was unable to be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

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: 17637394
• MDR Text Key: 322112352
• Report Number: 1820334-2023-01161
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10827002460383
• UDI-Public: (01)10827002460383(17)250725(10)14857752
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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: 14857752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• 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