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	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: rt.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 or Problem Description
It was reported an ultrathane cope nephroureterectomy stent was placed in the patient for nephroureteral drainage.The device was in place for approximately 2 weeks before leakage was confirmed by the facility.The device was then replaced with another like drain.As reported, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu) manufacturing instructions, quality control, specifications, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.One partial unlocked 8.5fr mac-loc catheter was returned for evaluation.The returned portion of the device was comprised of the mac-loc hub, connector cap and approximately 5cm of catheter tubing ending with a cut.The suture string also appeared to be cut.Biological matter was present on the device with no additional surface damage noted.A leak test was conducted and confirmed the presence of a leak between the connector cap and catheter tubing.Tug and twist tests revealed that the proximal assembly was secure.Upon removal of the connector cap, the suture string appeared to be normal within the threads.The flare appeared very damaged, but due to the compression of the flare within the cap and the potential for damage upon removal, it cannot be determined if the flare was manufactured to specifications.Additionally, a document based investigation evaluation was performed.Based on the current review of documentation, inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record was conducted and showed no relevant nonconformances in lot 8965863 that could have contributed to the reported failure mode.It should be noted that there were no other complaints reported for this lot number.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root 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.
Event or Problem Description
No new event description information to report at this time.

• 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: 7886632
• Report Number: 1820334-2018-02723
• Device Sequence Number: 11202016
• Product Code: LJE
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)210620(10)8965863
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: 06/20/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Device Lot Number: 8965863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 12/06/2018
• 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