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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Investigation- the product was not returned to assist with this investigation; however, a review of the device history, quality control (qc), and instructions for use (ifu) was conducted for the purpose of this investigation.Per quality control specification, the tethering is inspected, verifying proper placement of suture within the stent; proper type of suture; proper handle, location and length; a secure knot and ensuring the tether is not tangled around the stent.A review of the device lot records and non-conformance history did not observe any quality related concerns associated with this case.The ifu details: "the stent may be removed easily by gentle withdrawal traction using endoscopic forceps." based on the information provided, the root cause is undetermined.Additional action is not required at this time, the residual risk remains at an acceptable level.We will continue to monitor for similar complaints.

Event Description

A ureteroscopy with double j stent placement was being performed on the male patient.The stent was placed on (b)(6) 2016.The tether was left on the stent and the physician instructed the patient to remove stent using the tether after 48 hours.Sometime within the 48 hour period, the tether broke and was not found in the patient (patient voided tether).Stent was removed via cystoscopy by the implanting physician.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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 Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5454176
• MDR Text Key: 38793728
• Report Number: 1820334-2016-00098
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002234052
• UDI-Public: (01)10827002234052(17)180803(10)6090238
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UFH-624-RT1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2016
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/04/2016
• Date Device Manufactured: 08/03/2015
• 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