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

Catalog Number UNBS-6-15-CS

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

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

It is reported during a percutaneous nephrolithotomy (pnl) using a ultraxx nephrostomy balloon and set, the balloon became damaged and would not inflate.The physician percutaneously advanced the complaint balloon catheter over a wire guide and into the patient¿s body.Next, he utilized the radiopaque marker to ensure proper positioning of the balloon catheter, and attempted to inflate it.However, "inflation pressure did not rise since the balloon might have been damaged." the physician completed the procedure using another manufacturer's device instead.No adverse effects were experienced by the patient as a result of this alleged product malfunction.

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.Investigation ¿ evaluation reviews of the complaint history, device history record, documentation, instructions for use, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that the correct device was returned for investigation.The balloon material had a circumference rupture, with the split noted 15.5cm from the distal tip.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states ¿upon removal from the package, inspect the balloon catheter to ensure no damage has occurred during shipment.Defective devices should be returned to cook.¿ it goes on to say ¿do not exceed the maximum rated burst pressure for this balloon device.Do not pre-inflate the balloon.¿ then finally warns to ¿always inflate the balloon with a sterile liquid.Never inflate with air, carbon dioxide or any other gas.Do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.¿ based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be determined.We will continue our 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.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.

• 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: 8692376
• MDR Text Key: 147780980
• Report Number: 1820334-2019-01355
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002460379
• UDI-Public: (01)00827002460379(17)210920(10)9179609
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

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: 09/20/2021
• Device Catalogue Number: UNBS-6-15-CS
• Device Lot Number: 9179609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/20/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1