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

Model Number N/A

Device Problems Malfunction (2409); Device Operates Differently Than Expected (2913)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)

Event Type  Injury  

Event Description

The pt suffered hydronephrosis after the stent did not drain the kidney as expected.The stent was removed and a second cook stent was used.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

Event evaluation: a review of complaint history, instructions for use (ifu), quality control, specifications, and trends was conducted during the investigation.The product was not returned for evaluation.There is no evidence to suggest items in this lot were not manufactured in accordance to the current specification the ifu for the product states "complications of ureteral stent placement are documented.Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures." appropriate controls are in place.We will continue to monitor for similar complaints.It is possible that the stent may have become occluded during use due to a kink in the material.The root cause is determined to be due to product use during the procedure.The appropriate internal personnel has been notified.We will continue to monitor for similar complaints.

Event Description

The patient suffered hydronephrosis after the stent did not drain the kidney as expected.The stent was removed and a second cook stent was used.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4665106
• MDR Text Key: 5734378
• Report Number: 1820334-2015-00176
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2015

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: N/A
• Device Catalogue Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 04/02/2015
• 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