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

Catalog Number RMS-060024-R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Urinary Retention (2119); Surgical procedure, additional (2564)

Event Date 01/28/2015

Event Type  Injury  

Event Description

(b)(6) 2015: two resonance stents were placed through the urethra; one was for the left kidney and another was for the right one.(b)(6) 2015: the following symptoms were observed; a rise in creatinine level, hydronephrosis, pain complaint, weight increase and 100 ml of urine volume for two days.The physician judged that the symptoms were originated from kidney malfunction caused by the metal stents.Then, these two stents were removed from the patient and replaced with another manufacturer's stent.This report is directly related to mdr report ref# 3001845648-2015-00048.

Manufacturer Narrative

Incident meets reporting criteria of an fda mdr report as the removal and placement of the rms stents is viewed as surgical intervention to prevent a serious injury as the patient had developed hydronephrosis.No device malfunction has been reported, the device not draining is interpreted as a performance related issue.On evaluation of the returned resonance device the stent was noted to be the correct shape, it was confirmed that the rms stent was an (b)(4).No kinks or marks were visible on the stent.There were no signs of encrustation or blockages present within the coils on the stent.The wells of the stent were cut off and examined under the microscope.The safety wire was present and intact, no issue was noted.A wireguide was passed through the stent and it was confirmed that there was no occlusion inside the stent.There was no visual issue observed that could have caused the stent not to function as intended.No faults or defects were noted with the returned stent.A definitive cause for the customer's complaint was unable to be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy or progression of disease state, cook (b)(4) could not reproduce the actual conditions of device usage.The complaint was confirmed based on the customer's 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.As per instructions for use removal or replacement of a resonance stent is standard procedure.Potential adverse events associated with indwelling urethral stents include diminished urine drainage.A warning on the instructions for use advises the following: "patients should be checked at regular interval 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.A review of the manufacturing records for lot number c1004293 did not reveal any discrepancy related to the complaint issue.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: sinead quaid, sr. specialist ; 61334440
• MDR Report Key: 4605329
• MDR Text Key: 22150907
• Report Number: 3001845648-2015-00049
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial
• Report Date: 02/10/2015

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 Expiration Date: 05/28/2017
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1004293
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• 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