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

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: pre-amendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a drainage catheter from the ultrathane cope nephroureterectomy set was placed in the ureters of the patient for nephro-uretal drainage.After placement, the hub separated from the catheter.Another drainage catheter was placed successfully.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Investigation: evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest that the device was not made to specifications.A review of the device history record shows two nonconformances for incorrect placement of the marker band and another for excess glue, both of which were scrapped.Three nonconformances were found in catheter subassemblies for foreign matter and irregular coating, all of which were scrapped.Three nonconformances were found in the mac-loc subassembly for the insert not seated correctly and pinning error of which all were scrapped.It should be noted there were two other reported complaints associated with this lot number for the same failure.Based on the information provided, no returned product and the results of our investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.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
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7828646
• MDR Text Key: 118893685
• Report Number: 1820334-2018-02474
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)210607(10)8935221
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

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: Health Professional
• Device Expiration Date: 06/07/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 8935221
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 11/02/2018
• Supplement Dates FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1