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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 10/18/2018

Event Type  Injury  

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 Description

It was reported an ultrathane cope nephroureterectomy stent was placed in the patient for an unspecified procedure.An unspecified amount of time after placement, the stent was found to be leaking at the connection between the catheter and the hub.It is unknown if the device was replaced.Additional information regarding the event, patient demographics, and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Additional information: b5: additional information was received on 14nov2018.It was reported an ultrathane cope nephroureterostomy stent was placed in the patient's kidney for a nephroureterostomy procedure.After three days, the device was exchanged due to leaking at the hub.No other adverse effects were reported for this occurrence.H6 ¿ patient code: 3191 [no code available]- additional procedure required to replace device.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.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.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 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.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 revealed three relevant nonconformance's for lot 8900586, in which two devices were scrapped for an incorrect pattern of sideports, one device was scrapped for misplaced sideports and one device was scrapped for the loops not being in the same plane.Nonconformance's were also reported for catheter tubing subassembly lot sa8777894, as six devices were scrapped for rough coating, thirty devices were scrapped for foreign matter and one device was reworked due to the work order not being keyed out for the first lot.In a second catheter tubing subassembly lot sa8765905, fifteen devices were scrapped for coating defects and nineteen devices were scrapped for foreign matter.It should be noted that there was one other complaint reported for lot 8900586 and was reported for the same customer with the same failure mode.The instructions for use (ifu) advise the user to inspect the device prior to use to ensure that no damage has occurred.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.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.

• 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: 8052722
• MDR Text Key: 128248334
• Report Number: 1820334-2018-03339
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Device Lot Number: 8900586
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/14/2018; 12/19/2018
• Supplement Dates FDA Received: 12/06/2018; 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR