MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET

Catalog Number RMS-060028

Device Problem No Device Output (1435)

Patient Problem Surgical procedure, additional (2564)

Event Date 04/24/2015

Event Type  Injury  

Event Description

The resonance stent was not draining and the patient's creatinine levels kept increasing.The physicians performed a nephrostomy drainage and evolution of filtrate was changed.The resonance stent was removed from the patient.Following intervention, the patient recovered and creatinine levels went back to normal.No further adverse effects to the patient were reported.

Manufacturer Narrative

This particular rms-060028 device is currently not registered for sale in the us.However, this device is considered a "similar device" to other urinary tract stents/sets (metallic) devices currently registered for sale in the us.The 510(k)# for these urinary tract stents/sets (metallic) devices is as follows: k063742.Incident meets reporting criteria of an fda mdr report as the removal of the rms stents (and nephrostomy drainage) is viewed as surgical intervention to prevent a serious injury as the patient had developed hydroenphrosis.No device malfunction has been reported, but the device not draining is interpreted as a performance related issue.The complaint device reported was not returned to cook ireland for evaluation.With the information provided a document based investigation was carried out.A review of the manufacturing records for lot number c1021946 did not reveal any discrepancy related to the complaint issue.The complaint was confirmed based on the customer testimony.A possible cause of this complaint may be attributed to patient anatomy and progression of disease.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.A per instructions for use that accompanies this device, removal or replacement of a resonance stent is standard procedure.Potential adverse events associated with indwelling ureteral stents include urine drainage.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.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: RESONANCE STENT SET
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr. specialist ; limerick ; EI ; 61334440
• MDR Report Key: 4808046
• MDR Text Key: 5892692
• Report Number: 3001845648-2015-00117
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/24/2015

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 Expiration Date: 07/28/2016
• Device Catalogue Number: RMS-060028
• Device Lot Number: C1021946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/24/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/25/2015
• Initial Date FDA Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2014
• 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
• Patient Age: 75 YR