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

Model Number	N/A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: radiology.Pma/510(k) #: preamendment (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
It was reported a male patient required an ultrathane cope nephroureterectomy set placed for a bilateral nephroureterectomy catheter exchange on (b)(6) 2019.On (b)(6) 2020, the operator reported that the stent was "blocking" and was removed from the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D10 ¿ product received on: 24feb2020.Investigation ¿ evaluation: as reported, a 79-year-old male patient required placement of an ultrathane cope nephroureterostomy set for a right sided nephroureterectomy catheter exchange.Approximately two months after placement, the operator reported that a guidewire would not pass through the tip of distal loop.After two attempts, the operator elected to replace the device with another similar device.The operator reported the patient experienced some pain upon removal and cited it was likely caused due to sediment causing the distal loop of catheter to not fully uncurl during removal.No other adverse events were reported.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, as well as a visual inspection were conducted during the investigation.One used 8.5fr ult with biomatter was returned.The mac-loc was returned with the lever open.A white crusty substance was noticed on the distal pigtail.The catheter was flushed with water, the water was able to flush through without difficulty.The suture was missing from the mac-loc.The catheter was not visibly damaged.Additionally, a document-based investigation evaluation was performed.Appropriate controls are in place to detect this failure prior to distribution.The instructions for use (ifu) packaged with this device contains the following information: "this product is intended for use by physicians trained and experienced in placement of nephroureterostomy stents.Standard techniques should be employed." there are no known contraindications for placement listed in the ifu.The device history record (dhr) was reviewed.The final lot revealed two non-conformances and the catheter sub-assembly lots records one non-conformance.There is one applicable nonconformance for "surface defect.¿ the two nonconforming devices were scrapped.The are 100% inspections to check for surface defects.There are adequate inspection activities to capture nonconformances prior to distribution.A database search was completed on the final lot and no additional complaints were found.There is no evidence the complaint device was manufactured out of specification or nonconforming material from this lot exists in house or in the field.Additional information regarding the maintenance protocol and items injected through the catheter was received from the customer.Currently they do not have specific protocols in place for maintenance of these catheters.Based on the information provided, inspection of returned product, and results of the investigation, it was concluded that a maintenance issue and patient condition contributed to this incident.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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 was received on 17feb2020.The right nephroureterostomy was placed in the right renal collecting system.When the wire was advanced, it would not go through the top of the distal "loop".After two attempts to advance the wire, the wire passed through the tip.Upon removal of the device, the patient experienced "some pain presumably due to sediment causing the distal loop to not fully uncurl." the device was replaced with a new similar device to complete the procedure.

• 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: 9714182
• Report Number: 1820334-2020-00359
• Device Sequence Number: 2500362
• Product Code: LJE
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)220930(10)10050666
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 10050666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/17/2020; 04/23/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/10/2020; 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO GUIDEWIREBENSTON WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR