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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Customer (person): initial reporter is manufacturer quality engineer.Occupation: quality engineer.Pma/510(k) #: pre-amendment.Investigation - evaluation: a review of the complaint history, device history record, drawings, manufacturing instructions, instructions for use (ifu), quality control, specifications, as well as a functional test, visual inspection, and dimensional verification of the device was conducted during the investigation.Device # 1: clinical assessment: based on the device failure analysis, we found the actual failure mode for the device complaint to be too many threads showing.This is likely to be related to the leaking hub.A leaking hub could potentially cause inadequate drainage possibly resulting in infection or inability to drain.The most probable cause of this event is manufacturing related.Device #2: clinical assessment: based on the device failure analysis, we found the failure mode for the device complaint to be hub leakage.A leaking hub could potentially cause inadequate drainage possibly resulting in infection or inability to drain.The most probable cause of this event is manufacturing related.Five 8.5fr mac-loc catheters were returned for evaluation in unopened conditions in the original packaging.No damage was noted on the devices when they were removed from the packaging.Leak tests were performed and confirmed the presence of a leak in two of the returned catheters between the connecting cap and the catheter tubing.The number of threads showing for one of the leaking catheters was found to be too high during a specification analysis.Additionally, a document based investigation was performed.There are adequate controls in place to prevent the release of nonconforming product.A review of the device history record showed no relevant nonconformances that could have contributed to this failure mode.A review of the manufacturer's complaint database indicates there are two other relevant complaints with the device lot 9147537.These complaints are all related.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.Based on the information provided, the examination of the returned product, and the results of our investigation: device #1: we found the actual failure mode for the device complaint to be too many threads showing.Therefore the actual root cause for this failure mode is cause traced to manufacturing (manufacturing deficiency).We also found the failure mode for the device complaint to be hub leakage.No definitive root cause could be determined for this failure mode.Device # 2: we found the failure mode for the device complaint to be hub leakage.No definitive root cause could be determined for this failure mode.The appropriate personnel have been notified.Appropriate measures have been taken to address the hub leakage failure mode.Additionally, retraining was completed with the applicable assembler to address the too many threads showing failure mode.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.

Event Description

Manufacturer bench testing was performed for unused devices returned against medwatch report #1820334-2018-03288.During testing, two ultrathane cope nephroureterectomy stents were found to leak.These leakages are recorded under this medwatch report.The devices were returned unused and did not make patient contact.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8170559
• MDR Text Key: 130892728
• Report Number: 1820334-2018-03550
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)210907(10)9147537
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/17/2018

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
• Device Operator: Other
• Device Expiration Date: 09/07/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 9147537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1