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 Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The tether on the device appeared to stretch and then snapped.When the physician pulled the device out of the patient, there were a couple of random tether fragments on the device.The physician had to use forceps to remove these fragmented tethers.The physician elected to use a stent from another manufacturer to complete the procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Evaluation- a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions (mi), quality control (qc) and trends was conducted for the purpose of this investigation.Product was not returned to assist with this investigation.This product is manufactured per mi.The product is inspected per qc and has inspection for the tethering.The following is verified: proper placement of suture within the stent; proper type of suture; proper handle, location and length; a secure knot.Inspection assures that the tether is not tangled around the stent.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 unable to be determined or reported at this time.We will continue to monitor for similar complaints.

Event Description

The tether on the device appeared to stretch and then snapped.When the physician pulled the device out of the patient, there were a couple of random tether fragments on the device.The physician had to use forceps to remove these fragmented tethers.The physician elected to use a stent from another manufacturer to complete the procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.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: 5328863
• MDR Text Key: 34427643
• Report Number: 1820334-2015-00842
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UFH-626-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: 12/15/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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
• Patient Age: 67 YR