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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported the stiffener in an ultrathane cope nephroureterectomy set was difficult to remove.After the device was placed in the patient's right kidney, the user was unable to remove the stiffener from the catheter.The entire device was then removed and the procedure started over.Additional information regarding event details and patient outcome has been requested but is currently unavailable.
Event or Problem Description
In additional information received on 01jun2022, it was reported that the procedure was a nephroureteral stent exchange.The original access site was utilized, there was no new access.The patient did not experience any adverse effects or require additional procedures due to this occurrence.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Investigation / evaluation: on 25apr2022, a complaint was received from a representative at the (b)(6) hospital located in the city of (b)(6).Upon the placement of the ultrathane cope nephroureterectomy set (rpn: ult8.5-8.5-26-nucl-b-rh, lot: 14465225), the flexible stiffener became lodged in the tube while in place within the patient.The device was then removed, and the user had to start over.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures and specifications of the device, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used and damaged ultrathane cope nephroureterectomy set (rpn: ult8.5-8.5-26-nucl-b-rh, lot: 14465225) was returned for evaluation.The blue flexible stiffener was lodged inside of the catheter and was able to be removed during table-top testing by pulling on the tip of the catheter.Upon a visual examination of the blue flexible stiffener, kinks and material elongation were observed.Due to the condition of the flexible stiffener, re-insertion into the catheter was not possible.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for 14465225 found one possibly related nonconformance for "building material left in tubing,¿ in which one device was scrapped prior to further processing.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The product ifu, t_nucl_rev5, 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." evidence gathered upon review of the dhr, dmr, design history file, and complaint history, there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure without any design or manufacturing issue contributed to the reported event.The appropriate personnel have been notified.Per the 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.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14288960
• Report Number: 1820334-2022-00685
• Device Sequence Number: 5524623
• Product Code: FAD
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)250111(10)14465225
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

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 Expiration Date: 01/11/2025
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 14465225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 11/22/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/01/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown