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

Catalog Number UNBS-6-15

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during a percutaneous nephrolithotomy (pcnl), the user injected saline into a ultraxx nephrostomy balloon and set and found the balloon was leaking.The issue with this device was discovered prior to making contact with the patient, and the device was not used.An image of the device was provided which appears to show that the balloon was ruptured.A new device was used to complete the procedure.There was no impact to the patient.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during a percutaneous nephrolithotomy (pcnl), the user injected saline into a ultraxx nephrostomy balloon and set and found the balloon was leaking.The issue with this device was discovered prior to making contact with the patient, and the device was not used.An image of the device was provided which appears to show that the balloon was ruptured.A new device was used to complete the procedure.There was no impact to the patient.Investigation - evaluation.Reviews of the complaint history, device history record, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One package containing an ultraxx nephrostomy balloon and set was returned for investigation.Visual examination confirmed that the balloon was ruptured 14.5cm from the distal tip.The balloon material was completely torn all the way around the circumference.The balloon material had biological matter present at the distal tip.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the manufacturing instructions or quality control procedures.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Based on available evidence, cook has concluded that the most probable cause of the reported event could not be determined from the available information.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.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
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11321158
• MDR Text Key: 243042666
• Report Number: 1820334-2021-00321
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10827002460369
• UDI-Public: (01)10827002460369(17)220117(10)9454607
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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 Expiration Date: 01/17/2022
• Device Catalogue Number: UNBS-6-15
• Device Lot Number: 9454607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1