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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During placement of the stent into the patient at the end of the procedure over the wire, the pusher pushed up against the stent.A cut was made to remove the tether, and the tether broke when pulling it out of the patient.The remaining pieces were removed from patient with graspers.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation- a review of the complaint history, device history record, instructions for use(ifu), manufacturing instructions (mi) and quality control(qc) was conducted for the purpose of this investigation.Product was not returned to assist with this investigation.This product is manufactured to specifications per mi.The product is inspected per qc and 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.As the product was not returned, no physical evaluation could be completed.For this event, it is possible that the user exerted too much force while removing the stent, however, based on the available information, the root cause is undetermined.

Event Description

During placement of the stent into the patient at the end of the procedure over the wire, the pusher pushed up against the stent.A cut was made to remove the tether, and the tether broke when pulling it out of the patient.The remaining pieces were removed from patient with graspers.According to the initial reporter, the patient did not require any additional procedures nor 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: 5258356
• MDR Text Key: 32453217
• Report Number: 1820334-2015-00805
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

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: USH-626-RT1
• 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: 11/09/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2015
• 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