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

Catalog Number	ULT8.5-8.5-24-NUCL-B-RH
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: pre-amendment.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 following a successful percutaneous nephroureterectomy tube placement in the kidney's, the patient experienced complications approximately one hour into post-op.The patient presented with abdominal pain and was said to have malignant ureteral stenosis.A loss of urine from the right nephroureterectomy began and continued through the night.The physician checked the device the following day and determined the mac lock was not functioning as intended.The device was removed and another like device was used.As reported, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Concomitant medical products: neff introducer set, amplatz wire guide, terumo stiff wire guide (available at the time of the initial mdr).Device available for eval: yes; product received on: 27jun2018 investigation - evaluation conclusion codes: cause not established (4315).A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications and visual inspection/dimensional verification/functional test of the device was conducted during the investigation.The device was returned in a damaged state, with the catheter cut into two pieces.Dimensional testing demonstrated that the device was within the correct specifications and tolerances.Functional tests were also performed, confirming the failure mode.A leak test was performed, confirming the presence of a leak between the catheter tubing and mac-loc connector cap.A tug and twist test revealed the tubing was able to rotate inside the cap, indicating the flare was not attached to the hub.The flaring was also observed to be out of round and lopsided, but due to the potential damage upon removal during device failure analysis, it cannot be confirmed whether the flare was manufactured out of specification.After removing the connector cap, it was observed that the suture string was wound within the threads.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A device history review revealed nonconformances within the main lot (8482260).One for flare folded over fitting opening and one for foreign matter in the packaging.All devices were scrapped out.No nonconformances were found within the mac-loc subassembly lot (sa8425927).The catheter tubing subassembly lot contained two nonconformances related to the hydrophilic coating and were scrapped out.A search of the manufacturer's complaint database revealed that there were no other complaints associated with the lot 8482260.There is no evidence to suggest any product is nonconforming in house or out in the field.Based on the information provided, the device evaluation, and the results of our investigation, a definitive root cause could not be determined.This failure mode is being escalated per internal processes.The appropriate personnel will be notified and we 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 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: 7633272
• Report Number: 1820334-2018-01925
• Device Sequence Number: 1530218
• Product Code: LJE
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)210102(10)8482260
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: Lay User/Patient
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Device Lot Number: 8482260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention