MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; LJE CATHETER, NEPHROSTOMY

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
The customer reported that, shortly following placement of the device during a nephroureterostomy, the hub of the ultrathane cope nephroureterostomy set separated from the catheter portion off the device.The reported issue occurred twice during the procedure.(see related emdr# 1820334-2018-0366).The device had to be replaced to complete the procedure successfully.The customer confirmed that no additional procedures were necessitated by the product problem, and no patient adverse events resulted from the issue.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Please reference related mfr.Report: 1820334-2018-00366 as this event occurred with two devices from the same lot during the same procedure.Investigation evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and specifications as well as a visual inspection , dimensional verification and functional evaluation of the device was conducted during the investigation.Two 8.5fr catheters were returned.It is unspecified which is related to 1820334-2018-00366 or 1820334-2018-00368.One of the two catheters pulled out of the hub with the flare intact ("catheter 1").The second catheter is separated 1.7cm distal of the hub ("catheter 2").The edge of the separation appears to be smooth, indicating it may have been cut.Both catheters were returned separated into several pieces.A black liquid was noted on the interior of the devices, indicating they were likely used.The catheter outer diameters, flare diameters, and cap inner diameters were all found to be within cook's manufacturing specifications.However, because the hub was pulled out of the fitting for "catheter 1" and the fitting for flare 2, it is possible that the diameters of the flares were distorted.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.A database search revealed one other reported complaints for this lot number-reported under 1820334-2018-00366.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause is therefore related to the manufacturing process.This failure mode was escalated per internal processes.The appropriate personnel have been contacted and cook will continue to monitor for similar complaints.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: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Common Device Name: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7280834
• Report Number: 1820334-2018-00368
• Device Sequence Number: 19105076
• Product Code: LJE
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)201218(10)8453841
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 05/21/2018

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 Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1