MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

Model Number G49867

Device Problems Calcified (1077); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Unspecified Kidney or Urinary Problem (4503)

Event Date 03/13/2022

Event Type  Injury  

Event Description

As reported, a universa firm ureteral stent set was placed in the patient because they had a ureteral stone.The patient had a follow up visit six months after stent placement and using ultrasound it was discovered that the stent was encrusted on both pigtails (kidney and bladder loops) and also on the stent body.The patient was not urinating well and was in pain and the stent was removed.The patient had to undergo a laser lithotripsy procedure to remove the encrustations from the stent with the laser.No section of the device remained inside the patient¿s body.No additional patient consequences were reported.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Event summary: as reported, a universa firm ureteral stent set was placed in the patient because they had a ureteral stone.The patient had a follow up visit six months after stent placement and using ultrasound it was discovered that the stent was encrusted on both pigtails (kidney and bladder loops) and also on the stent body.The patient was not urinating well and was in pain and the stent was removed.The patient had to undergo a laser lithotripsy procedure to remove the encrustations from the stent with the laser.No section of the device remained inside the patient¿s body.No additional patient consequences were reported.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation.The device was not returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.The device is provided with instructions for use which caution, ¿ureteral stents should be checked periodically for signs of encrustation and proper function.¿ the ifu lists occlusion, encrustation, and loss of renal function as potential adverse events associated with the use of the device.Based on the available information and a clinical assessment of the event, cook has concluded that a cause for this event could not be established.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNIVERSA FIRM 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: 13891529
• MDR Text Key: 287835610
• Report Number: 1820334-2022-00451
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002498679
• UDI-Public: (01)00827002498679(17)240615(10)14026897
• Combination Product (y/n): N
• PMA/PMN Number: K161236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G49867
• Device Catalogue Number: UFH-528
• Device Lot Number: 14026897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male