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 Urinary Retention (2119); Surgical procedure, additional (2564)

Event Date 05/09/2015

Event Type  Injury  

Event Description

The patient was suffering with cancer of the cervix and had a rms-060024-r stent placed in both urinary ducts transurethrally on (b)(6) 2015.The stents were placed for a long period placement, however hydronephrosis relapsed 3 months after replacement.The complaint devices were replaced with new rms stents for both urinary ducts.The laboratory results confirm the patient is stable.This report addresses one rms-060024-r stent.An additional separate report will be submitted in relation to the second stent.Report reference number 3001845648-2015-00122 will address the second device.There have been no adverse effect to the patient.

Manufacturer Narrative

Incident meets reporting criteria of an fda mdr report as the removal and replacement of the rms stents is viewed as surgical intervention to prevent a serious injury as the patient had developed hydroenphrosis.No device malfunction has been reported, the device not draining is interpreted as a performance related issue.1 x rms-060024-r stent of an unknown lot number was returned for evaluation.On evaluation of the returned stent it was noted to be the correct shape.A kink was observed on one of the pigtails, but the cirl senior manufacturing engineer commented that this was probably as a result of the removal of the stent possibly using forceps.There were no signs of encrustation or blockages present within the coils on the stent when they were examined visually by the cirl senior manufacturing engineer.The wells of both ends of the stent were cut off.The safety wire was present and intact.A wireguide was passed through the stent and resistance was met just as the exit of the curl.When the stent was cut at the blockage area it was confirmed that the stent was occluded.When the stent was examined under the microscope the cirl senior manufacturing engineer commented that the occluded matter had the texturing of encrustation/calcification.The complaint was confirmed as the stent was occluded.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 ireland could not reproduce the actual conditions of device usage.A possible cause of the occlusion of the stent may be attributed to patient anatomy, treatment the patient was receiving or 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.Prior to distribution all resonance stent devices are subject to visual inspections to ensure device integrity.The lot # of the resonance stent device involved in this complaint was not provided, therefore it was not possible to check the relevant manufacturing records.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 ; 61334440
• MDR Report Key: 4840239
• MDR Text Key: 5914901
• Report Number: 3001845648-2015-00123
• 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: 05/13/2015

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-060024-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/09/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 30 YR