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

Catalog Number USH-600

Device Problem Occlusion Within Device (1423)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the physician utilized the universa soft ureteral stent set with large stone burdens during a ureteroscopy.The stent broke up the stones; however, there were still fragments.The stent was completely pinched off and led to hydronephrosis (ballooning effect of the kidney).The physician admitted that it may have been due to the large stone burden.The stent and stone fragments were removed and a new stent was placed which worked successfully.A section of the device did not remain inside the patient¿s body.The patient did require an additional procedure due to this occurrence. the patient had to have the stones removed and a new stent placement.According to the initial reporter, the patient did experience an adverse effects due to this occurrence.Since the stent was pinched; it caused hydronephrosis.

Manufacturer Narrative

Investigation ¿ evaluation: the complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.No lot number was provided so additional product of the same lot could not be pulled from stock for analysis.The investigation included a review of the instructions for use and specifications.A review of the device history record could not be performed as the lot number of the device was not provided.A search for additional complaints on the same lot could not be carried out without the device lot number.The instructions for use (ifu) provides the following: individual variations of interaction between stents and the urinary system are unpredictable.Ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.Complications of ureteral stent placement are documented.These complications include, but are not limited to: extravasations.Occlusion.Migration.Hemorrhage.Sepsis.Perforation of the urinary tract.Peritonitis.Encrustation.Urinary tract infection.Loss of renal function.Occlusion of the ureteral stent is mentioned as a potential adverse event in the ifu and is a known inherent risk of the device.A document review was carried out and no anomalies could be found with production or inspection process.A clinical assessment was carried out that concluded that the most probable causes of this event are human anatomy or disease progression related.However, device failure and medical procedure related causes cannot be entirely ruled out.The complaint report included comments from the physician who indicated that the large stone burden in the patient may have contributed to the event.Based on the available information the probable cause is the patient¿s anatomy or disease progression.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7432956
• MDR Text Key: 105560316
• Report Number: 1820334-2018-00970
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: USH-600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 05/14/2018
• 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
• Patient Outcome(s): Required Intervention