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

Model Number N/A

Device Problems Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Age: over 60 years old.Concomitant medical products: it was reported the operator either used a.035 bentson wire, glidewire, or magic torque wire.Occupation: ivr technologist.Pma/510(k) #: pre-amendment.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an ultrathane cope nephroureterostomy set was selected for use in an unknown patient for a nephroureterostomy exchange procedure.As reported, difficulty was experienced while advancing the stiffening cannula, but it was able to be placed.Difficulty was again experienced while removing the stiffener.As stated by the initial reporter, "(the) stiffener stretches upon intended removal but ultimately they get it out without a breakage occurring." as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.Reviews of the complaint history, device history record, drawings, instructions for use, manufacturing instructions, quality control, and specifications of the device were 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.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The current risk controls in place are adequate to prevent the failure mode from occurring and the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record found no related non-conformances for the complaint lot or corresponding subassembly lots.A review of complaint history records found three other complaints from the same lot.These three complaints were from the same user facility, so it is possible that user technique contributed to the failure mode.There is no evidence to suggest there is any nonconforming product in house or out in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: "activate hydrophilic coating, if present, by wetting surface of device with sterile water or saline.For best results, maintain wetted condition of device during placement." instructions for use: stent placement "1.Using standard percutaneous access technique, establish wire guide position well into the bladder.2.Over the wire guide, introduce the stent/stiffening cannula into the kidney collecting system.3.After establishing proper proximal and distal position, push the stent off the stiffening cannula over the wire, making sure the distal pigtail forms within the bladder." how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the information provided, no returned product and the results of the investigation, it was concluded that component failure without design or manufacturing issue contributed to the 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 Description

No additional patient or event information has been received since the last report was submitted on (b)(6) 2019.

• 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: 8916547
• MDR Text Key: 155343563
• Report Number: 1820334-2019-02064
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481732
• UDI-Public: (01)00827002481732(17)220509(10)9727939
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-22-NUCL-B-RH
• Device Lot Number: 9727939
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1