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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

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 nephrostomy using an ultraxx nephrostomy balloon and set, the balloon leaked.The balloon was inserted into the patient and advanced over a guidewire.The urologist then attempted to inflate the balloon with the inflation device, but the balloon did not inflate.The balloon was withdrawn from the patient and again was unsuccessfully attempted to be inflated.A small hole was then noted in the balloon.The device did not come in contact with any metal objects.A new 18fr ultraxx balloon was used to continue the procedure.No unintended part of the device remained inside the patient's body.No additional procedures were required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.

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 nephrostomy using an ultraxx nephrostomy balloon and set, the balloon leaked.The balloon was inserted into the patient and advanced over a guidewire.The urologist then attempted to inflate the balloon with the inflation device, but the balloon did not inflate.The balloon was withdrawn from the patient and again was unsuccessfully attempted to be inflated.A small hole was then noted in the balloon.The device did not come in contact with any metal objects.A new 18fr ultraxx balloon was used to continue the procedure.No unintended part of the device remained inside the patient's body.No additional procedures were required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, specifications, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.The device was not returned for investigation.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.A review of relevant manufacturing documents was conducted.No gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ based on the available information, cook has concluded that a cause for the hole in the balloon could not be determined.Cook will continue monitoring of similar complaints and has 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: 12301520
• MDR Text Key: 265828268
• Report Number: 1820334-2021-01950
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10827002460369
• UDI-Public: (01)10827002460369(17)231230(10)NS13657424
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

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: 12/30/2023
• Device Catalogue Number: UNBS-6-15
• Device Lot Number: NS13657424
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1