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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Pma/510(k) #: preamendment.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 an unknown patient required the placement of an ultrathane cope nephroureterostomy set for an unknown procedure.The operator reported that after placement in the kidney/bladder, " the inner stylet was getting stuck in the drain." the device was replaced with a device from the same lot number and experienced the same failure.No other adverse effects were reported for this incident.
Event or Problem Description
The two complaint devices were returned on 12feb2020.One of the catheters was returned with the flexible stiffener inserted.This catheter and stiffener combination was separated at the same location.It is currently unknown if the device was cut or separated upon removal.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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
Additional information received 27apr2020 stating that the catheter was not cut.The whole catheter was removed and another similar device was placed.Additionally, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional information: b5.D10 ¿ product received on: 12feb2020.Investigation ¿ evaluation: it was reported that the flexible stiffeners from two ultrathane cope nephroureterostomy sets became stuck in the catheter after placement.Each catheter was removed and replaced with a new device.Cook became aware of this event upon being notified by a physician from (b)(6) university hospital.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.Two catheters and two flexible stiffeners were returned with light amounts of biological matter on the surface.One catheter has the stiffener inserted and both the catheter and stiffener are separated.The cut is at 4.5 cm from the distal end of the cap.There is elongation noted along the stiffener.The stiffener was able to be removed from the catheter hub section without resistance.No additional damage was noted to the separated catheter and stiffener.The other catheter is undamaged.The other stiffener is kinked and was not inserted into the catheter.This stiffener was attempted to be advanced into this catheter and became lodged within the catheter at the first loop.The tubing was cut to measure the inner diameter of the catheter.All relevant dimensions (stiffener outer diameter and catheter inner diameter) were measured within specification.The separated stiffener¿s outer diameter was elongated/damaged.Additionally, a document-based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The product ifu states the following in consideration of the reported failure mode: precautions ¿ this product is intended for use by physicians trained an experienced in placement of nephroureterostomy stents.Standard techniques should be employed.¿ activate hydrophilic coating, if present, by wetting surface of device with sterile water or saline.For best results, maintain wetted condition of device during placement.How supplied ¿ upon removal from package, inspect the product to ensure no damage has occurred.The device history record (dhr) was reviewed.The lot and related subassembly lots revealed no nonconformances.A complaint database search was performed and revealed no other complaints at the time of this investigation.Since there are no related nonconformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.A capa is currently open to address this issue.Based on the information provided, visual inspection of returned devices, and results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Common Device Name: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9555288
• Report Number: 1820334-2020-00063
• Device Sequence Number: 11511544
• Product Code: LJE
• UDI-Device Identifier: 00827002481626
• UDI-Public: (01)00827002481626(17)221007(10)10066116
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2020

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: 10/07/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-22-NUCL-B-RH
• Device Lot Number: 10066116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/12/2020; 04/27/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 02/28/2020; 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1