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

Catalog Number UNKNOWN

Device Problem Occlusion Within Device (1423)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

The device was not available for return to cirl for evaluation therefore a documentation based investigation was completed.The customer complaint could be confirmed based on customer testimony and review of the images provided by the customer as encrustation was visible.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, removal or replacement of a resonance stent is standard procedure.Potential adverse events associated with indwelling ureteral stents include and are not limited to stent encrustation.A warning in 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¿.An exact rpn or lot number were not provided, therefore a review of the manufacturing and component records could not be completed.Prior to distribution all resonance stent devices are subject to visual inspections to ensure device integrity as per internal procedures outlined in cirl.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Dr.(b)(6) stated he removed the resonance stent earlier than expected (9 months versus close to 12) due to encrustation and obstruction.The patient had no complications, it was a straightforward stent removal/exchange.

• 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: 5864467
• MDR Text Key: 51724118
• Report Number: 3001845648-2016-00202
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/15/2016
• Initial Date FDA Received: 08/10/2016
• 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