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 Codes	No Information (3190); No Code Available (3191)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device available for evaluation: unknown.Occupation: charge tech.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 an ultrathane cope nephroureterectomy stent was placed in a patient during the "summer" of 2018.An unspecified amount of time after placement, the catheter was found to be leaking at the connection between the catheter and the hub.It is unknown if the catheter was replaced.Additional information regarding the event, patient demographics, and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
D10 ¿ product received on: 11jan2019.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 of unused returned product, were conducted during the investigation.Three unused devices from the same lot were returned in the original packaging for inspection.Visual inspection and dimensional verification found all of the devices to be undamaged and within correct specifications.Leak testing was performed on all three devices.Leaking was confirmed on one device where the catheter tubing meets the connector cap.This device leak has been recorded under medwatch report #1820334-2019-00181.Leaking was not confirmed on either of the other two devices.A review of the device history record for the complaint lot revealed one related non-conformance due to too many adapter threads showing.Three devices were scrapped out prior to lot release for this nonconformance.No related non-conformances were reported for the device subassemblies.It should be noted that there were three other complaints reported for this lot from the same customer with the same failure mode, but all three were related to the same reported incident.Based on the information provided, the examination of returned product, and the results of our investigation, a definitive root cause could not be established.Measures are being conducted to address this failure mode.The appropriate personnel have been notified.Cook 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.
Event or Problem Description
No new information has been added to the description of event since the previous medwatch report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Patient code: 3191 [no code available]- additional procedure required to replace device.Additional information was received on 14nov2018.It was reported an ultrathane cope nephroureterectomy stent was placed in the patient's kidney for urine drainage.Nine days later, the drain was exchanged due to leakage at the hub.This event is recorded under this medwatch report (1820334-2018-03338).The next day, the replacement drain was found to be leaking and was exchanged again for a new drain of the same type.This event is recorded under medwatch report #1820334-2018-03340.As reported, the patient did not experience any other adverse effects due to this occurrence.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 8052500
• Report Number: 1820334-2018-03338
• Device Sequence Number: 11173825
• Product Code: LJE
• UDI-Device Identifier: 00827002481664
• UDI-Public: (01)00827002481664(17)210129(10)8544564
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2019

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: 01/29/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-26-NUCL-B-RH
• Device Lot Number: 8544564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 01/18/2019
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/06/2018; 02/07/2019
• 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
• Patient Age: 56 YR