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

Catalog Number	UNBS-10-15-CS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional: buyer.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 was reported, during a percutaneous nephrolithotomy (pcnl) using a ultraxx nephrostomy balloon and set, the stopcock was letting out pressure and fluid.When starting to inflate the balloon, the stopcock was letting out pressure and fluids (1/2 contrast and 1/2 saline).The stopcock was leaking where it tightens to the catheter.The balloon was inflated/deflated two times.The stopcock was then removed and the inflation device was connected directly to the balloon without the stopcock.The procedure was successfully completed.According to the initial reporter, the patient did not experience any adverse effects due to the alleged malfunction.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.It was reported, during a percutaneous nephrolithotomy (pcnl) using a ultraxx nephrostomy balloon and set, the stopcock was letting out pressure and fluid.When starting to inflate the balloon, the stopcock was letting out pressure and fluids (1/2 contrast and 1/2 saline).The stopcock was leaking where it tightens to the catheter.The balloon was inflated/deflated two times.The stopcock was then removed and the inflation device was connected directly to the balloon without the stopcock.The procedure was successfully completed.Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.Visual examination of the returned device confirmed the stopcock only was returned in used condition, while the catheter, sheath and inflation device were not returned.No visible anomalies were observed on the stopcock.Function test performed by flushing the stopcock with tap water.When it was in the open position water flushed freely thru the fitting.In the closed position no leak was detected.The turn knob functioned properly when turned to open then close position.A review of the device history record found one non-conformance related to the reported failure mode.This non-conformance was for a failed leak test that was found during the manufacturing process and the device was discarded.Due to the individual leak testing of each device, on nonconformance in the lot is not indicative of other devices in the lot.There is no indication nonconforming product was released.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: always inflate the balloon with sterile liquid.Never inflate with air, carbon dioxide or any gas.Do not over inflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.Precautions: do not exceed the maximum rated burst pressure (listed on label) for this balloon device.Do not pre-inflate the balloon.Refer to product label or the inflation check valve on the balloon device for appropriate balloon volume.Sphere inflation device: before use ensure the connector tubing is completely free of air.Do not reuse or resterilize the sphere inflation device.Read instructions prior to use.Potential adverse events: complications that may occur during this procedure include over inflation of the balloon, which could result in trauma to the surrounding tissue.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The cause for the reported failure mode could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 new patient or event information to report.

• 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: 9831048
• Report Number: 1820334-2020-00607
• Device Sequence Number: 743059
• Product Code: LJE
• UDI-Device Identifier: 00827002303577
• UDI-Public: (01)00827002303577(17)230106(10)10246282
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K024050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 01/06/2023
• Device Catalogue Number: UNBS-10-15-CS
• Device Lot Number: 10246282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1