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

Catalog Number	UNBS-6-15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It is reported during a percutaneous nephrolithotomy using a ultraxx nephrostomy balloon and set, the balloon ruptured.The complaint device was advanced over the wire guide percutaneously to the target lesion, and the user attempted to inflate the balloon with 20 atm with inflation device which was included in the same package.However, balloon ruptured around 18 atm.Another device of the same rpn was used instead to complete the procedure.No adverse effects to the patient have been reported as a result of this alleged product malfunction.The patient did not require any additional procedures as a result of this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that an unopened inflation device was returned to cook for investigation.A functional leak test was performed, but the balloon would not inflate.Upon further visual examination, a split was noted in the balloon device.The balloon material had ¿tread marks¿ on the surface of the balloon material.The balloon appeared to have been damaged by another device used in the procedure.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 manufacturer¿s instructions, specifications, drawings, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states ¿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¿refer to the product label or inflation check valve on the balloon device for appropriate balloon volume.¿ 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 established.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.
Event or Problem 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
• Common Device Name: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8691656
• Report Number: 1820334-2019-01293
• Device Sequence Number: 11264047
• Product Code: LJE
• UDI-Device Identifier: 00827002460362
• UDI-Public: (01)00827002460362(17)191109(10)NS7430194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K024050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2019
• Device Catalogue Number: UNBS-6-15
• Device Lot Number: NS7430194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1