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

Model Number N/A

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Event Description

It was reported that the stiffener of two ultrathane cope nephroureterostomy set separated during a percutaneous nephrolithotomy procedure (pcnl).Resistance was felt during attempted removal of the stiffener from the stent.The stiffener was removed halfway when it separated.As result, the entire stent was removed from the patient.Another of the same device was used, and the same incident occurred again.The procedure was completed successfully with a work-around performed by the physician.The physician used a 1:1 ratio of contrast and saline during the procedure and suggested that could be a possible reason for the difficult removal.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

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.

• 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: 18573409
• MDR Text Key: 333624974
• Report Number: 1820334-2024-00113
• Device Sequence Number: 1
• Product Code: FAD
• 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
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• 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: ULT10.2-10.2-26-NUCL-B-RH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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