MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; FAD STENT, URETERAL

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: department manager.Pma/510(k) #: k171603.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 unknown patient required an ultrathane cope nephroureterectomy set for a nephroureterectomy stent placement.During the procedure, the stiffener could not be removed.The device was removed and another similar device was placed to complete the procedure successfully.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, unavailable, or unchanged.Investigation - evaluation richard franklin from university of maryland in the united states informed cook of an incident involving an ultrathane cope nephroureterostomy set [rpn: ult8.5-8.5-26-nucl-b-rh] from lot number 10008474.On (b)(6) 2020, during a procedure, the stiffener could not be removed from the catheter.The device was removed from the patient and a new device was used to complete the procedure.No unintended section of the device remained inside the patient¿s body, the patient did not require additional procedures due to this occurrence, and there have been no adverse effects to the patient due to this occurrence.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications, as well as a visual inspection and dimensional verification of the returned device, was conducted during the investigation.One used 8.5 ult was returned to cook for evaluation.Upon visual inspection, the flexible stiffener was noted to be separated inside of the catheter.The stiffener hub was also separated.The catheter was cut and the stiffener was removed.The catheter inner diameter and flexible stiffener outer diameter were measured and found to be within manufacturing tolerance.Cook has concluded that this device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (10008474) and the related catheter subassembly and raw material lots revealed no non-conformances relevant to the reported failure mode.A database search did not identify any other events associated with the reported device lot.As there are adequate inspection activities established, there is objective evidence that the dhr was fully executed, there are no related non-conformances, and no additional complaints from the same lot were found, cook has concluded that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, t_nucl_rev4, 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.5.Over the wire guide, introduce the stent/stiffening cannula into the kidney collecting system.6.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.7.Remove the stiffening cannula from the stent, leaving the wire guide in place.¿ how supplied "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event has been traced to a deficiency in manufacturing/device design.Appropriate measures have been taken to address this failure mode.A capa was previously opened to address this failure mode with this device.It should be noted that the complaint device was manufactured prior to implementation of corrective activities.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 information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11061424
• MDR Text Key: 223709092
• Report Number: 1820334-2020-02357
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)220912(10)10008474
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

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: 09/12/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 10008474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 05/05/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1