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

Catalog Number RMS-060026-R

Device Problem Occlusion Within Device (1423)

Patient Problems Renal Failure (2041); Test Result (2695)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

It has been indicated that the resonance stent device involved in this complaint is being returned to cook ireland for evaluation, however the device has not been received to date.With the information provided a document based investigation was carried out.The patient¿s pre existing condition was unknown.The complaint was confirmed based on the customer testimony.Resonance stent devices are used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.These devices are intended for one-time use.As per instructions for use, potential adverse events associated with indwelling ureteral stents include diminished urine drainage and hydronephrosis.A warning on the instructions for use advises the following: ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).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¿.A final warning indicates that: ¿individual variations of interaction between stents and the urinary system are unpredictable¿.Prior to distribution all resonance stent devices are subject to visual inspections to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for lot number c1089232 did not reveal any discrepancy related to the complaint issue.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

After placement of the resonance stent on (b)(6) 2015, gradual increase of creatinine level and development of hydronephrosis had been observed.The user determined kidney malfunction caused by suspicion of occlusion of the stent, and removed the stent from the patient on (b)(6) 2015.Other manufacturer's plastic stent was placed after removal of resonance stent.Removal and replacement of resonance stent is viewed as surgical intervention to prevent serious injury as the patient had developed hydronephrosis and the device is suspected as occluded.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5293343
• MDR Text Key: 33414858
• Report Number: 3001845648-2015-00282
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060026-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/17/2015
• Event Location: Hospital
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2015
• 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