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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: intervention radiologic technologist.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 that the stiffener in an ultrathane cope nephroureterostomy set was difficult to remove during the procedure.As the user was attempting to place the catheter in the patient, the device was flushed but the stiffener was "sticking to the catheter" and could not be removed.As a result, the device was removed and a new set was placed to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 or Problem Description
In additional information received on 12jan2022, it was reported that the procedure being completed was a percutaneous nephroureteral internal external stent placement.The catheter was able to be advanced over the catheter easily.When the physician went to remove the flexible stiffener, resistance was experienced.The catheter was unable to be separated from the introducer even though the catheter had been flushed prior to placing it over the wire.The flexible stiffener was able to be unscrewed from the catheter, but was unable to be removed from the catheter, causing buckling of the catheter.The device was then removed as a unit, disassembled, flushed and reassembled.Once again, the flexible stiffener was unable to be removed.A second catheter was opened, flushed and inserted without issues.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
On 23dec2021, cook medical received a complaint from a representative from the (b)(6) regarding an ultrathane cope nephroureterostomy set (rpn: ult8.5-8.5-26-nucl-b-rh; lot: #14216697).It was reported that during the procedure, a percutaneous nephroureteral internal external stent placement, difficulty removing the stiffener was encountered.The catheter was able to be advanced over the catheter easily.When the physician went to remove the flexible stiffener, resistance was experienced.The catheter was unable to be separated from the introducer, even though the catheter had been flushed prior to placing it over the wire.The flexible stiffener was able to be unscrewed from the catheter, but was unable to be removed from the catheter, causing buckling of the catheter.The device was then removed as a unit, disassembled, flushed and reassembled.Once again, the flexible stiffener was unable to be removed.As a result the entire device was removed, and a second catheter was opened, flushed and inserted without issues.A review of the complaint history, device history record (dhr), specifications, quality control procedures, and instructions for use (ifu) were conducted during the investigation.One ultrathane cope nephroureterostomy set was returned in a used and damaged condition.The blue flexible stiffener was lodged inside the catheter.During table top testing, by pulling on the tip of the catheter, the blue flexible stiffener was able to be removed.Upon a visual examination of the blue flexible stiffener, two kinks and material elongation were noted at approximately 10.7cm and 12.5cm, when measuring from the distal end of the yellow hub.A bend in the shaft of the flexible stiffener was discovered to be present, measuring from the distal end of the fitting at approximately 11.9 cm.Table top testing confirmed the stiffener would not fully advance into the lumen of the drainage catheter.A dissection of the catheter was performed, verifying the i.D.Was within specification.Additionally, the o.D.Of the flexible stiffener was measured to be within specification.There is no evidence to suggest that product was not manufactured to current specifications.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 dhr for the complaint lot 14216697 and subassembly lot sa14027501confirmed there were no relevant recorded nonconformances.Additionally, the supplied tubing lot numbers 2154496.1 and 2163471.1 were confirmed to not have abnormalities recorded during the incoming inspection process.Since there is objective evidence the dhr was fully executed, and there are no other lot-related complaints that have been received from the field, cook has concluded that there is no evidence that non-conforming product exists in house or in the 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.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." based on the information provided, inspection of the returned device, and the results of the investigation, the catheter and stiffener were manufactured to specification.Cook medical will conclude the root cause category would fall under cause traced to component failure, being defined as component failure without any design or manufacturing issue.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• 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: 13170019
• Report Number: 1820334-2022-00023
• Device Sequence Number: 1689316
• Product Code: FAD
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)240916(10)14216697
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2024
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 14216697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 01/12/2022; 09/26/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/18/2022; 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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