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

Catalog Number UFH-600-R

Device Problem Difficult to Remove (1528)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 08/07/2014

Event Type  Injury  

Event Description

During a stent exchange, the stent in the renal pelvis knotted.This resulted in the physician removing the stent percutaneously.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation.

Manufacturer Narrative

(b)(4).Actual product was not returned, no device evaluation was possible.The product was not returned; therefore, no physical evaluation of the device could be completed.However, during the course of investigation, a review of complaint history, drawing, instructions for use (ifu), manufacturing instructions (mi) and quality control (qc) was conducted.This device is supplied with an instructions for use (ifuo that states the universa firm stents must not remain in dwelling for more than 12 months and that stents are not intended for permanent implantation.Each of these units are 100% inspected by quality control personnel; however, the stents knotting within the patient cannot be detected prior to a shipping it is suggested to conduct periodic evaluation either cystocopic, radiographic, or ultrasonic means to observe any encrustation that may have occurred; should be encrustation or knotting affect the effectiveness of the stent during drainage, it should be replaced.The ifu also cautions that there have been documented complications with ureteral stent placement.The use of ureteral stents should consider the risk-benefit factors as applicable to the patient.The functionality of the stent is verified per quality control specification.Based upon the available information, a definitive root cause cannot be determined.We will continue to monitor for similar reports of this nature.Per the quality engineering risk assessment (qera), no further action is required at this time.

Event Description

During a stent exchange, the stent in the renal pelvis knotted, this resulted in the physician removing the stent percutaneously according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4254554
• MDR Text Key: 5105340
• Report Number: 1820334-2014-00577
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: UFH-600-R
• Device Lot Number: U2412673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/07/2014
• Device Age: 10 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• 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