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

Catalog Number RMS-060026

Device Problem Contamination (1120)

Patient Problem Swelling (2091)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

The stents' removal as a result of the swelling of both the kidneys can be viewed as intervention - therefore this event mdr criteria of a 'serious injury' report.This complaint is related to 1 x rms-060026 device of lot#c1103858.1 x rms-060026 device of an unknown lot number was returned to cirl for evaluation.On inspection of the device the encrustation seen was considered normal and within expected level for the indwell time reported.Encrustation has been considered as a potential failure mode in the risk document.On flexing of the stent, the movement of the device was also considered normal tip of the device was cut by the senior manufacturing engineer to evaluate possible blockage of the stent.0.035¿ guide wire was inserted and safety wire removed.Guide wire could move freely and no blockage was noted.As encrustation levels based on the 5 month in-dwell in the patient were considered normal and no blockage was found within the device, a definitive root cause cannot be determined.Complaint was confirmed based on the customers¿ testimony.Prior to distribution all rms-060026 devices are subjected to visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for the complaint lot and associated sub-assemblies revealed no discrepancies related to this complaint issue or occurrence.As per the instructions for use (ifu) that accompanies this device, ¿warnings¿ section: ¿individual variations of interaction between stents and the urinary system are unpredictable.Use of this device should be based on consideration of risk-benefit factors as they apply to your patient.¿ also as per the ifu ¿potential adverse events¿ associated with indwelling ureteral stents include:diminished urine drainage/stent occlusion, hydronephrosis, pain/discomfort, pyuria, stent encrustation and tissue ingrowth.It was noted in the complaint that the patient did not experience any adverse effects due to this occurrence and did not require any additional procedures.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

During the extraction of the two stents the physician has noticed that the stents could have a kind of protein coating.Physician thinks that it could have caused the swelling of both kidneys.As per the above description of event received, two devices are involved in this incident.This report addresses the investigation of 1 x rms-060026 device of lot#c1103858.An additional report will be submitted in relation to the other rms-060026 device reported - report reference number: 3001845648-2015-00198.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 5143882
• MDR Text Key: 28026825
• Report Number: 3001845648-2015-00197
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 09/14/2015

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 Catalogue Number: RMS-060026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/14/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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 Age: 61 YR