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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.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 the stent from an ultrathane cope nephroureterectomy set leaked after placement.The leak occurred at the location the hub joins the catheter.A new, similar stent was placed to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D10 ¿ product received on: 04apr2019.Investigation/evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, dimensional verification, and functional test, were conducted during the investigation.The complainant returned one partial catheter in a used and damaged condition to cook for investigation.The device attributes were measured and the number of threads showing between the hub and cap were found to be out of specification.A leak test was conducted and confirmed the presence of a leak.Tug and twist tests were conducted and confirmed that the proximal assembly was secure.Investigators could recreate the reported failure mode.The device did leak and was out of specification per manufacturing instructions ¿ too many threads showing.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record for this lot and similar device lots found no relevant non-conformances.It should be noted there are no other reported complaints for these lots.Based on the information provided, inspection of the returned product and the results of the investigation, a definitive cause was established as manufacturing deficiency - too many threads showing.Appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.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.(necessary).
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8413015
• Report Number: 1820334-2019-00620
• Device Sequence Number: 1827715
• Product Code: LJE
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)210905(10)9139531
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Device Lot Number: 9139531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1