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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign body, removal of (2365); No Code Available (3191)

Event Date 11/25/2014

Event Type  Injury  

Event Description

The stent was initially placed with no issues.After some period of time, the stent appeared broken on x-ray.The stent was broken in the middle into two pieces while still in the patient.They were able to retrieve the stent.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

Lot # not provided by reporter.Catalog # not provided by reporter.Expiration date unknown as lot # is unknown.Udi # unknown as lot # is unknown.(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), and quality control was conducted during the investigation.No product was returned for evaluation.There is no evidence to suggest that the device was not made to specification.The ifu states ¿improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.¿ and cautions ¿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.¿ and ¿individual variations of interaction between stents and the urinary system are unpredictable¿ due to the complaint product not being returned, a root cause can not be determined.The appropriate internal personnel has been notified.We will continue to monitor for similar complaints.

Event Description

The stent was initially placed with no issues.After a period of time, an x-ray was taken, which revealed the stent was broken in the middle (into two pieces) while still in the patient.They were able to retrieve the stent.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 4377104
• MDR Text Key: 5238933
• Report Number: 1820334-2015-00005
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2014

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
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/25/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• 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
• Patient Outcome(s): Required Intervention