MAUDE Adverse Event Report: COOK INC KWART RETRO-INJECT URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number 003500

Device Problems Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer occupation = unknown.Pma/510(k) number = exempt.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, 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

It was reported that a kwart retro-inject ureteral stent became knotted during a ureteroscopy and stent removal procedure.When the user attempted to remove the stent from the ureter, knots were noted and the stent was difficult to remove.The user spent approximately 45 minutes attempting to remove the stent.Stent was finally removed with no adverse issues or patient injury.It is unknown when the stent was implanted.It was reported that the stent was not being monitored prior to removal.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction - d9, h3: device evaluated by mfg = other (81) - the device has not been received by cook and there have been no updates from the customer regarding the return of the device.If the device is returned at a later date the complaint will be reopened and updated accordingly.Event summary: it was reported that a kwart retro-inject ureteral stent became knotted during a ureteroscopy and stent removal procedure.When the user attempted to remove the stent from the ureter, knots were noted and the stent was difficult to remove.The user spent approximately 45 minutes attempting to remove the stent.Stent was finally removed with no adverse issues or patient injury.It is unknown when the stent was implanted.It was reported that the stent was not being monitored prior to removal.Investigation ¿ evaluation: a document based investigation was performed including a review of instructions for use (ifu), interview personnel, and quality control procedures of the device were conducted.The device was not returned to cook for investigation.Cook was unable to complete a review of the device history record (dhr) as the lot number for the stent set was unknown.Given the above procedures, cook has concluded that current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The device is provided with instructions for use which warns, "formation of knots in multi-length stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal.¿ based on the available information, cook has concluded the cause of the knots was unable to be determined; however, this is a known possible event to occur with the use of multi-length stents.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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: KWART RETRO-INJECT URETERAL STENT 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: 16592794
• MDR Text Key: 312199099
• Report Number: 1820334-2023-00298
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 003500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2023
• 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