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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.G4 ¿ 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.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

It was reported that the stiffening cannula of an ultrathane cope nephroureterostomy set was difficult to remove from the stent.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

Additional information was received.The procedure was completed by using a different drain.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b3, b5, e1, e3 e3- occupation: lead tech 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 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 or that a death or serious injury occurred; nor is it admission 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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.It was reported that the stiffening cannula of an ultrathane cope nephroureterostomy set was difficult to remove from the stent.The procedure was completed by using a different drain.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu) of the complaint 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.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 dhrs for the reported complaint device lot and the related subassembly lots revealed one relevant non-conformance for "catheter, length incorrect".This device was scrapped prior to further processing of the order.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot number.An expanded search of final lots comprising of the same catheter subassembly lot or flexible stiffener subassembly lot found 34 additional lots.Review of these lots confirmed there have been no additional complaints received for the same failure mode.Cook medical has concluded there is no evidence that non-conforming product exists in house or in the field, and that the device was manufactured to current specifications.Cook also reviewed product labeling.The ifu, t_nucl_rev5, [cope nephroureterostomy stents] packaged with the device contains the following in relation to the reported failure mode: "instructions for use: 3.Flush the catheter with sterile normal saline or water.4.Insert the stiffening cannula into the catheter and lock it in place.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." based on the information provided, no product returned, and the results of the investigation, cook concluded that the cause of this event could be traced to 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
• Type of Device: 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: 18627310
• MDR Text Key: 334389376
• Report Number: 1820334-2024-00159
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002481688
• UDI-Public: (01)00827002481688(17)241119(10)14366722
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

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 Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-28-NUCL-B-RH
• Device Lot Number: 14366722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/21/2024; Not provided
• Supplement Dates FDA Received: 02/27/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1