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

Model Number G49877

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

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

As reported, the patient had an appointment (date unknown) to remove a universa firm ureteral stent, but the doctor found that the stent was covered with stones.Citrate was given to the patient to dissolve the stones and the patient was scheduled to return three months later to remove the stent.The patient returned three months later to have the stent removed.During the procedure, the patient experienced unspecified ureteral damage and a lot of bleeding.The amount of blood loss was requested and we received a response that they were unable to estimate the amount of blood loss.The patient was admitted to the hospital for observation.It was reported that the stent was in the patient approximately six months and that the stent was not being monitored.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

Event summary: as reported, the patient had an appointment (date unknown) to remove a universa firm ureteral stent, but the doctor found that the stent was covered with stones.Citrate was given to the patient to dissolve the stones and the patient was scheduled to return three months later to remove the stent.The patient returned three months later to have the stent removed.During the procedure, the patient experienced unspecified ureteral damage and a lot of bleeding.The amount of blood loss was requested and we received a response that they were unable to estimate the amount of blood loss.The patient was admitted to the hospital for observation.It was reported that the stent was in the patient approximately six months and that the stent was not being monitored.No additional patient consequences were reported.Investigation ¿ evaluation: a document based investigation was also performed including a review of complaint history, device history record (dhr), personnel interview, instructions for use (ifu), and quality control procedures.The device was not returned to cook for investigation.A review of the device history record for the complaint device was conducted and no relevant non conformances were found.A search of customer complaints regarding lot 14600718 was also conducted and no additional complaints were noted.A device failure analysis was not able to be conducted as the device was not returned to cook.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.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which cautions, "precautions: ureteral stents should be checked periodically for signs of encrustation and proper function." the ifu also states, "potential adverse events: ¿encrustation.¿ based on the available information, cook concluded the cause of the encrustation was unable to be determined with the available information.Procedural and patient factors were unable to be ruled out as potential encrustation causes.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.

• 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: 15838160
• MDR Text Key: 304094835
• Report Number: 1820334-2022-01755
• Device Sequence Number: 1
• Product Code: FAD
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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: G49877
• Device Catalogue Number: UFH-600
• Device Lot Number: 14600718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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): Hospitalization