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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Pma/510(k) #: exempt.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 ultrathane cope nephroureterostomy stent was placed in the patient for a nephroureterostomy procedure.The next day, the stent was confirmed to leak from the area the stent attaches to the hub.This report documents the initial leakage.The stent was then replaced with another stent that also leaked from the same area.Medwatch 1820334-2018-02694 documents this second leak.Another stent of a different size was used to complete the entire placement successfully.As reported, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Corrected data: date of event: (b)(6) 2018.Investigation evaluation: a review of the complaint history, device history record, and documentation 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.Risk specifications covering mac-loc drainage catheters include both hub separation and leakage as potential failure modes, and technical files indicate that the risks associated with these devices are acceptable when weighed against the benefits.The instructions for use (ifu) instruct the user to inspect the product prior to use to ensure that no damage has occurred.Based on the review of current documentation, there is no evidence to suggest issues or gaps in existence that could contribute to the release of nonconforming product related to the reported failure mode.A review of the device history record was completed and found one relevant nonconformance in lot 8482260 for a flare folded over the fitting opening, in which the one device affected was scrapped.It should be noted that there were two other complaints associated with this lot number.Based on the information provided, no returned product and the results of our investigation, a definitive cause could not be determined.Three possible root causes have been identified as the suture string running through the threads of the cap assembly interfering with the seal during torqueing, an inconsistent flaring process and the silicone insert being punctured during production due to improper threading technique.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been 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: 7881893
• Report Number: 1820334-2018-02638
• Device Sequence Number: 19424568
• Product Code: LJE
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)210102(10)8482260
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 11/14/2018

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: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Device Lot Number: 8482260
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/14/2018
• 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