MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Catalog Number RMS-060024-R

Device Problems Break (1069); Occlusion Within Device (1423)

Patient Problems Occlusion (1984); No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2014

Event Type  malfunction  

Event Description

The patient was diagnosed with retroperitoneal fibrosis and had 2 resonance stent's placed in (b)(6) 2013.With the scope in the bladder, the physician noted that both stents were encrusted with stones.More force than usual was needed to remove the first stent but he was able to remove the stent.The second stent appeared to be more difficult to remove than the first one, coming only half way out of the ureter.Watching down live fluoro, the stent was stuck mid ureter and was tugging on the anatomy, not moving.After extensive pulling the physician was able to remove the second stent, however, the stent had completely uncoiled.The physician shot a retrograde fluoro and the patient's ureter appeared to be intact.Two new stents, same size, were placed.This report is being submitted relating to the second stent only that broke on removal.No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

No adverse effects to the patient are reported as occurring.The stent completely unraveled at one end upon removal from the patient.An fda mdr report is required based on the reporting precedence established for this product family for stent fracture; regardless of patient outcome.The device involved in this complaint has not been returned for evaluation to date; as a result of document based investigation was carried out.In the potential adverse events section of the instructions for use stent encrustation is listed.Images were received and were reviewed by the relevant personnel.As per the image review stent encrustation may have weakened the stent enabling the physician to break the internal wire.It is noted however that the force required to break the internal wire is quite high.It is possible the user broke the internal wire by exerting excessive force.The user is provided the following advice in the advice in the instructions for use relating to force when removing the device: "do not force components during removal or replacement.Carefully remove the components if any resistance is encountered." as per the complaint description provided the user has indicated extensive pulling was utilized when removing the device.The customer complaint could be confirmed based on customer testimony.Prior to distribution all resonance stent devices are subject to visual inspections to ensure device integrity.Stent encrustation is listed as a potential adverse event in the instructions for use.It also states to carefully remove the stents and not to use force.A 100% stress test is performed on the stent during production and it is confirmed at finished quality inspection stage.From the information provided the patient did not experience any adverse effects due to this occurrence.The device was successfully removed and replaced with two new stents of the same size.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; 61334440
• MDR Report Key: 4260750
• MDR Text Key: 19766202
• Report Number: 3001845648-2014-00164
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2014

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 Catalogue Number: RMS-060024-R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/07/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/11/2014
• Initial Date FDA Received: 09/04/2014
• 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